S-LIFT Surgical Technique DOC50002 rev.k S-LIFT Surgical Technique

Transcription

1 S-LIFT Surgical Technique DOC50002 rev.k S-LIFT Surgical Technique

2 Quick Steps: S-LIFT at a Glance Table of Contents About S-LIFT Introduction 3 Features & Benefits 4 Standard Technique Preoperative Planning 5 Patient Positioning 6 1. Dissection 2. Dilation 3. Retractor Dissection 7 Tissue Dilation 8 Assemble the Retractor System 9 Discectomy 10 Distraction and Sizing 11 Assembling the Inserter 12 Assembling the Implant 13 Inserting the Implant 14 Releasing the Implant 15 Verifying Implant Position 16 Closure Discectomy 5. Sizing 6. Secure Implant Additional Technique Notes Proper Use of T-Handle 18 Insertion of Shaft 19 Insert Verification 20 Removal of Shaft from Handle 21 Revision 22 About the System Package Insert 23 Indications & Sterilization 24 Case Assembly Insert Implant 8. Release the Implant 9. Verify Implant Position Instruments 25 1 S-LIFT Surgical Technique S-LIFT Surgical Technique 2

3 Anatomy of S-LIFT About SpineFrontier SpineFrontier was founded by practicing spine surgeons with the belief that, as surgeons, we are best able to identify our own needs as well as those of our patients. Our team of surgeons, engineers and industry experts collaborate seamlessly on our innovations, helping us develop SpineFrontier into a company that is driven to be a leader in cutting edge technology. Our mission is to focus on our needs as surgeons, allowing us to improve patient care through innovative technologies. Large central cavity for bone graft The lateral approach provides a safe technique for a large interbody The open backed design allows for additional bone graft packing The implant has a large footprint for stability The system is designed for a minimal incision insertion SpineFrontier would like to thank all the surgeons that contributed to the development of the S-LIFT Lateral Interbody System and the surgical technique. Features & Benefits About the LES Philosophy LES, or Less Exposure Surgery, is the philosophy of achieving optimum surgical exposure while maximally preserving the anatomy and lessening the exposure to radiation and damaging effects of surgical techniques. It optimizes surgical access, use of radiation, muscle dissection, anatomy removal, and implant selection into one pivotal focus: less exposure with optimal visualization. Large central cavity for bone graft The implant has a large footprint for stability The lateral approach provides a safe technique for a large interbody The open backed design allows for additional bone graft packing The system is designed for a minimal incision insertion Robust lateral access retractor for positional stability LESS, Less Exposure Segmental Spine Surgery, is a component of the LES philosophy. LESS is the practice of applying the LES philosophy to spine surgery securing one segment at a time and repeating procedures segment by segment. About the System Each multi-level condition in the spine could be treated and repeated for adjacent segments, said Kingsley R. Chin, M.D. The future of spine surgery is dependent upon devices and techniques for less exposure segmental spine surgery. About the LES Society The S-LIFT Intervertebral Body Fusion Device is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The SpineFrontier S-LIFT Intervertebral Body Fusion Device is intended to be used with supplemental spinal fixation system(s) cleared for use in the lumbar spine (example: Facet Screw Fixation). The LES Society seeks to advance research, education and technology for tissue sparing treatments that allow for ease of application for the surgeon with improved outcome for the patient. The LES Society is a non-profit, tax-exempt, educational organization whose purpose is to protect the health of the patient and to optimize the surgical procedure for the surgeon by promoting the less exposure surgeon philosophy. The society provides a forum for dialogue amongst spine surgeons and gives them a place to discuss and debate the LES approach, as well as train and contribute to educational endeavors. It will also be a resource to other physicians and patients on the benefits of LES and the latest technologies all in the effort to ease patient healing time post-surgery. The implants are provided in two configurations: straight and lordotic (8 ). Implants sizes for both configurations are offered with a fixed width of 22mm, lengths from 38mm 58mm (in 5mm increments) and heights from 8mm 16mm, in 2mm increments. The S-LIFT Intervertebral Body Fusion Device components are supplied non-sterile, are single use, and are fabricated from PEEK-OPTIMA LT1 with markers for radiographic visualization. Surgical Technique Symbols Warning Additional Information 3 S-LIFT Surgical Technique S-LIFT Surgical Technique 4

4 1 Surgical Procedure 2 Patient Positioning All necessary imaging studies should be available to visualize patient anatomy and plan implant placement. The neurophysiologist or neuromonitoring technician should apply all appropriate electrodes prior to patient positioning. The patient is positioned in a lateral decubitus. A soft support between the patient and operating table may be used to help maintain positioning. Secure the patient to the table with tape. Care must be taken throughout the procedure to ensure that no damage is caused to the nerve roots. Within the S-LIFT System certain instruments are designed to allow striking while others are not. Avoid striking instruments without a strike plate. Striking instruments that do not have a strike plate may damage the instruments and it will affect the performance of those instruments. Please note that the Inserter has pinch points. Care must be taken not to get gloves caught in the pinch points when opening and closing the Inserter. It s recommended to use a flexible table and position the iliac crest over the table break. Slight flexion may be applied to open the patient s flank, but avoid maximum flexion which tensions lumbar roots across the lateral aspect of the vertebral body and disc space. 5 S-LIFT Surgical Technique S-LIFT Surgical Technique 6

5 4 Tissue Dilation 3 Dissection Insert the Stage One Dilator into the retroperitoneal space down to the psoas muscle. Assemble the accessory handle to the Monopolar Stimulating Probe. Use lateral fluoros to confirm the target segment and to mark the initial incision. Make a skin incision targeting the anterior third of the disc space. Separate the abdominal oblique muscles with blunt dissection and enter the retroperitoneal space. Insert the Monopolar Stimulating Probe assembly in the Stage One Dilator. With the assistance of the neurophysiologist or neuromonitoring technician, use the dilator and probe assembly to map out a safe path through the psoas muscle to the lumbar spine by stimulating with the Probe. Stop your approach and investigate your positioning if the triggered EMG response is generated. Move the peritoneum anterior with forefinger and continue blunt dissection to palpate down to the psoas muscle. SI00112 Guidewire Outer Stage Two Dilator Once on the disc space, carefully hold the dilator in place and remove the probe and handle assembly. Confirm the proper dilator position with fluoro. Use the dilator holder to keep hands free of direct fluoro exposure. Insert the guidewire through the dilator and continue your dilation procedure to largest dilator Inner Stage Two Dilator Outer Probe Access Dilator, Stage 2 Assemble the Inner Stage Two Dilator by sliding the Outer Stage Two Dilator over the Inner Stage Two Dilator. The probe can be used through the access ports of the Inner Stage Two Dilator to ensure safe dilation. SI50057 Accessory Handle, Nerve Monitoring Probe Care must be taken throughout the procedure to ensure that no damage is caused to the nerve roots Dilator Holder Within the S-LIFT System certain instruments are designed to allow striking while others are not. Avoid striking instruments without a strike plate. Striking instruments that do not have a strike plate may damage the instruments and it will affect the performance of those instruments. Please note that the Inserter has pinch points. Care must be taken not to get gloves caught in the pinch points when opening and closing the Inserter. 7 S-LIFT Surgical Technique S-LIFT Surgical Technique 8

6 5 Assemble the Retractor System With the dilator on the disc space, determine the blade length needed by reading the dilator markings at the skin.insert the three appropriate length blades in the retractor blade slots and tighten down the set screws with the driver. The assembled retractor is inserted over the Stage Two Dilator. The probe can be used through the blade access port to ensure safe insertion. Use AP fluoroscopy to verify that the blades are parallel and in contact with the end plates. Attach the Rail Clamp to the table rail, slide into the desired position and turn the Rail Clamp handle (bottom) clockwise to tighten clamp. Turn the arm clamp handle (side) counter-clockwise to open the arm clamp opening. Insert the articulating arm post into the Rail Clamp opening, set the desired angle and vertical position and lock it into place by tightening the arm clamp handle. With the central articulating arm knob partially tightened to allow controlled movement, attach the instrument holder end to either of the two side mounting locations on the retractor. While ensuring the retractor is still in the previously set position, fully tighten the central articulating arm knob. 6 Discectomy Remove the dilators and guidewire. Incrementally open the blades. The cephalocaudal blades are Create an incision through the annulus with the Annulus Cutting Knife or Scalpel. opened by squeezing the retractor handles. The AP blade is opened by rotating the side paddles. Anchor screws can be inserted into center slot of the cephalocaudal blades to fix the blade position to the vertebral body. Choose the proper sized anchor screw relative to blade length. SI50077 Retractor Scalpel Annulus Cutting Knife Release the contralateral annulus and shave the cartilaginous endplates with the Cobb Elevators. Continue along the endplates of the disc space and cut through the contralateral annulus. Ensure that the Cobb does not cut past the contralateral annulus by continually working under fluoro. The lighting assembly has a clip attached to the illumination end. This clip is inserted into the retractor blade rail from the top of the blade. Set the depth of the light as required and bend back the remaining length over the retractor away from the working portal. Attach the lighting assembly to the light cord and attach the light cord to the light source. SI50031 Cobb, 20mm Cobb, 16mm Use Rongeurs, Curettes and other disc preparation instruments to thoroughly evacuate the disc material. Use the Rasp on the endplate to expose bleeding bone. SI50097 Rail Mount Articulating Arm The Hohmann Retractor can be used to retract anterior tissue anchoring the tip through the annulus. SI02090 Curette, Oval Straight XX Blades Care must be taken during this step of the procedure to ensure that no damage is caused to the nerve roots. Optional: Add extension blades by assembling Extension Blade to Extension Blade Inserter and sliding blade down the retractor blade rails until it has engaged detents. Press Extension Blade past ratcheting XX Anchor SI50046 Rasp, Straight After the evacuation of the disc material, ensure residual material is removed from around the disc site. detents until desired length has been achieved. SI50103 Light Cable SI50090 Pituitary Rongeurs, Straight 4mm Avoid excessive removal of the endplate cortical bone which could result in subsidence or reduced segmental stability. SI50207 Pituitary Rongeurs, Straight 6mm SI50107 Hex Driver, 3mm When assembling the retractor blades, avoid using the Hex Driver to back out the set screws beyond the retractor thread limit and/or excessively tighten the set screws. Excessive tightening may cause the tip of the hex driver or the set screw to fracture Lighting To minimize the risk of residual disc material around the dura, the initial incision can be biased to the anterior side. Avoid excessive retraction to ensure no damage is caused to the soft tissue and nerve roots Hohmann Retractor 9 S-LIFT Surgical Technique S-LIFT Surgical Technique 10

7 Slap Hammer Connection Trial Markers: 58mm 53mm 48mm 43mm 38mm 8 Assembling the Inserter 7 Distraction and Sizing Assemble the Inserter by inserting the retention shaft down to the unlocked detent position. Paddle Shavers are used to prepare the disc space and provide initial distraction. Connect an appropriately sized Paddle Distractor to the T-Handle (see additional notes for details). Heights are provided in 8mm, 10mm, 12mm, 14mm and 16mm and length of 48mm. Heights are undersized by 0.5mm relative to the implant to ensure a tight fit Mallet Connect an appropriately sized trial to the T-Handle. Insert the Trial into the disc space. Light malleting may be required to advance the Trial. Use fluoro to confirm the fit and orientation of the spacer for proper implant sizing. The center material between the openings of the Trial should line up with the spinous processes in an AP view. If necessary, insert alternate trials to find the most secure fit. The trials are 48mm long with markers at 38mm, 43mm, 53mm and 58mm, which are used as a reference to define the proper length implant. Remove the Trial. If assistance is needed, slide the Slap Hammer on the Trial shaft and tap the Trial out Slap Hammer Trial 8mm Trial 10mm Trial 12mm Trial 14mm Trial 16mm SI5000 Inserter Assembly If using the Paddle Shavers to prepare the disc space the aggressive bone removal feature may create a larger disc space than intended. Size should be verified with Trials. It is important to select the correct size implant. If the implant is too small expulsion may occur. If the implant is too large subsidence Paddle Distractor 8mm may occur Paddle Distractor 10mm Paddle Distractor 12mm Paddle Distractor 14mm 11 S-LIFT Surgical Technique Paddle Distractor 16mm S-LIFT Surgical Technique 12

8 UNLOCK LOCK 9 Securing the Implant to the Inserter 10 Inserting the Implant Assemble the proper size implant onto the jaws of the Inserter in such a way that it bottoms out on the back of the jaws. Turn the retention shaft to the lock position. Pull on the implant to verify it is secure. The interior of the implant can now be packed with bone graft material. Insert the implant into the prepared disc space. Continually use fluoro to monitor proper orientation and position. Optional: Assemble the outer sleeve to the Implant Holder prior to the Lock Shaft. Screw down the outer sleeve in the clockwise position to a firm stop at the secure position for additional When using lordotic implants, use fluoroscopy to verify proper orientation of lordosis. support. SI5000 Inserter Assembly SI5000 Inserter Assembly Ensure that the outer sleeve is in the release position when assembling the implant. Once the outer sleeve stops at the secure position, do not apply additional clamping force. x 13 S-LIFT Surgical Technique S-LIFT Surgical Technique 14

9 OFF AXIS AP Center 1 Leading Edge 2 Trailing Edge OFF AXIS AP 12 Verifying Implant Position 11 Releasing the Implant Release the implant by turning the retention shaft clockwise to the unlock position and sliding the jaws off the implant. After insertion, verify position and orientation of the implant using AP and lateral fluoros. The implant has five (Figure A) or seven (Figure B) markers; one at the leading edge, two or four in the center and two at the trailing edge. In the AP fluoro, correct orientation is defined when the center markers line up with the trailing edge markers vertically. Proper placement is defined when the center markers line up with the spinous processes. Ensure the lock shaft is set to the unlock position and the outer sleeve, if used, is set to the release position when releasing the implant. Pull back on the outer sleeve handle or implant holder shaft when removing the inserter after implant release. Pulling on the lock shaft strike plate only may cause disassembly of the lock shaft. In the lateral fluoro, correct orientation is defined when the trailing edge markers are in the same position as the center markers relative to the leading edge. If the implant is over-inserted or not in the desired placement, re-engage the Inserter then lock and secure the implant. Adjust to the optimal position as needed and follow the implant release procedure. SI5000 Inserter Assembly Use the Impactor to advance the implant if needed. Additional bone graft material can be packed into the back opening of the implant and around the implant using the Graft Funnel and Pusher. When using the Bone Funnel check your position to be sure the tip is in the position of intent before striking. The tip of the bone funnel may core or damage soft tissue if placed incorrectly. Excessive bone graft packing could affect the tight fit of the implant thus increasing the risk of subsidence or could affect the placement of the implant. Verify implant fit and position with fluoro. Avoid excessive Graft Pusher striking as it could push the implant out of position. Verify implant position with fluoro. 15 S-LIFT Surgical Technique S-LIFT Surgical Technique 16

10 13 Closure 14 Additional Notes: Proper Use of the T-Handle Verify the absence of significant bleeding in the disc space or psoas muscle. Remove the retractor system per the manufacturer s instructions. Close the skin using standard subcuticular suture. The quick connect T-Handle is used in conjunction with all Trials and Paddle Shavers. The following instructions demonstrate how to assemble the T-Handle to the shafts and how to disassemble the T- Handle from the shaft. Shaft insertion into the handle: When inserting the instrument shaft into the handle, grasp the handle and push forward on the connector as far as it will go; this pushes the ball spring mechanism out of the way. SI50023 T-Handle 17 S-LIFT Surgical Technique S-LIFT Surgical Technique 18

11 15 Additional Notes: Insertion of Shaft 16 Additional Notes - Insert Verification Next, grasp the instrument shaft in the other hand and insert the 1/4 square end into the handle connector Gently pull on the shaft. You might not hear or feel anything if the shaft is already engaged. as far as it will go (with the connector still pushed forward). Once the engagement is verified, pull again on the shaft. It should retain securely in the handle even Now release the connector; it should spring back slightly. under very strong pulling or pushing forces. This check should be done upon each assembly of the handle to an instrument shaft. Glove may pinch into the instrument. 19 S-LIFT Surgical Technique S-LIFT Surgical Technique 20

12 18 Revision Revision could be necessary under the following situations: A. Intra-operative Revision 1. Larger implant preferred after initial implant inserted 2. Misplaced implant; too anterior or not straight 3. Implant placed too far into disc space 4. Implant fracture during impaction/insertion 5. Wrong level surgery 6. Loss of neurologic function of unknown cause B. Post-Operative Revision 1. Non-Union 2. Infection 3. Subsidence into endplates 4. Psychological patient fear of having a device in forever 5. Painful hardware irritating soft tissues or nerves 6. Cage migration causing neural compression 7. Vertebral body fracture around cage leading to cage malposition The following steps are taken to revise the implant. 1. Set the Inserter to the unlock position. 2. Capture the implant with the Inserter jaws and seat the Inserter against the implant. A/P and lateral fluoros can be used to verify position. 17 Additional Notes: Removal of Shaft from the Handle To remove the instrument shaft from the handle, grasp the shaft in one hand and the T-Handle in the other, without pulling. Use your fingers to push forward on the connector in a squeezing motion. This will retract the ball spring mechanism. With the connector still pulled back, you can pull the instrument shaft out of the handle. 3. Set the inserter to the locked position. Glove may pinch into the instrument. 4. Pull on the Inserter to explant the interbody. Tap a Mallet on the underside of the strike plate if additional assistance is needed for removal. 5. Unlock the Inserter and remove the explanted interbody. 6. Optional: If there are any obstructions preventing placement of the Inserter lock shaft, then the outer sleeve can be used with the implant holder to clamp on the interbody and facilitate removal. 21 S-LIFT Surgical Technique S-LIFT Surgical Technique 22

13 The S-LIFT System Extension Shim Tool Extensor Inserter SI50058 Tissue Dilator Stage Stage 2 Dilator Extension Blade Inserter SI50023 T-Handle SI00321 T-Handle, Pull SI00090 Straight Handle, Pull T-Handle, Pull SI02200 T-Handle, Pull T-Handle, Pull, Cannulated Mallet SI50090 Pituitary Rongeurs, Straight, 4mm Pituitary Rongeurs, Straight, 6mm SI50055 Pituitary Rongeurs, Straight, 8mm Pituitary Rongeurs, Pistol Grip, Straight, 12in, 4mm Pituitary Rongeurs, Pistol Grip, Straight, 12in, 6mm mm Rongeurs, 10in Impactor Outer Stage 2 Dilator Impactor, Offset SI50016 Nerve Monitoring Probe Monitoring Probe, 294mm SI50077 Retractor Set Screw Scalpel SI02835 Graft Funnel SI02170 Graft Funnel Graft Funnel, Implant Holder Assembly XX XX Blades Blades Annulus Cutting Knife Guidewire Guidewire 1.6mm x 352 mm SI02160 Graft Pusher XX Anchor SI50031 Cobb, 20mm Cobb, 16mm Bent Cobb, 16mm Bent Cobb, 20 mm SI50052 Cobb, 16mm SI50021 Cobb, 20mm Cobb, 16mm Straight Cobb, 20mm Straight Cobb, 16mm Bent Cobb, 20mm Bent Bipolar Forceps S Bipolar Forceps Bipolar Forceps Cord, 12ft Articulating Arm SI50097 SI50103 Light Cable Bifurcated Light Cable Fiber Optic Cable, 3.5MM Aperture , , , Adapters Rail Mount SI50000 Inserter Assembly Inserter, Lock Shaft, Slap Hammer Inserter, Implant Holder, Slap Hammer SI02090 Curette, Oval Forward Angled Forward Angled Cupped Curette Long SI02080 Curette Rectangular Box Curette Box Curette Long Rectangular Curette Rectangular Curette, Long Shaft SI50046 Rasp, Straight Bone Rasp Long Rasp, E-LIFT Slap Hammer XX (08,10,12,14,16) Rev C Paddle Distractor, Long Shaft Paddle Distractor 8mm Paddle Distractor 10mm Paddle Distractor 12mm Paddle Distractor 14mm Paddle Distractor 16mm Recovery Distractor 10mm Recovery Distractor 12mm Recovery Distractor 14mm Recovery Distractor 16mm Recovery Distractor 18mm Trial 8mm Trial 10mm Trial 12mm Dilator Holder Suction, Suction, 12 SI50107 Hex Driver, 3mm Lighting SI50030 Lighting Low Profile Lighting SI02070 Curette, Oval Straight Cupped Curette Long SI02090 Forward Angled Curette Foward Angled Cupped Curette, Long Trial 14mm Trial 16mm SI50024-XX (01, 02, 03, 04, 05) Trial XX (04, 06, 08,10,12,14) Trial, Straight, 22mm Wide XX (04, 06, 08,10,12,14) Trial, 19mm Wide XX (08, 10, 12, 14, 16) Trial, Lordotic, 19mm Wide Trial S-LIFT 6mm Droplet Curette Droplet Curette, Angled Extension Blade, Straight Extension, Straight, Bent Tab Extension Blade, Pointed Extension, Pointed, Bent Tab Pointed Extension Shim, Short Prong Pointed Extension Shim, Long Prong S-LIFT Surgical Technique Hohmann Retractor Hohmann Retractor Hohmann Blade, 10MM Wide, Curved Handle Hohmann Gate, Studs Angled Droplet Curette SI50042 Penfield Retractor Penfield, Pusher Nerve Root Retractor, 45 Degrees Trial Rasp, 8mm x 22mm Tapered Trail Rasp, 8mm x 22mm Trail Rasp, 10mm x 22mm Trail Rasp, 12mm x 22mm Trail Rasp, 14mm x 22mm Trail Rasp, 16mm x 22mm XX (06, 08, 10, 12, 14) Trial Rasp, Straight, 22mm Wide XX (06, 08, 10, 12, 14) Trial Rasp, 19mm Wide XX (08, 10, 12, 14, 16) Trial Rasp, Tapered XX (08, 10, 12, 14, 16) Trial Rasp, Lordotic, 19mm Wide S-LIFT Surgical Technique 24

14 The S-LIFT Assembly S S-LIFT, Split Rib, Straight, 19mm, 8X38mm L S-LIFT, Split Rib, Lordotic, 19mm, 12X48mm IM Interbody, Straight, 14mm x 53mm S S-LIFT, Split Rib, Straight, 19mm, 10X38mm L S-LIFT, Split Rib, Lordotic, 19mm, 14X48mm IM Interbody, Straight, 16mm x 53mm S S-LIFT, Split Rib, Straight, 19mm, 12X38mm L S-LIFT, Split Rib, Lordotic, 19mm, 16X48mm IM Interbody, Straight, 8mm x 58mm S S-LIFT, Split Rib, Straight, 19mm, 14X38mm L S-LIFT, Split Rib, Lordotic, 19mm, 10X53mm IM Interbody, Straight, 10mm x 58mm S S-LIFT, Split Rib, Straight, 19mm, 8X43mm L S-LIFT, Split Rib, Lordotic, 19mm, 12X53mm IM Interbody, Straight, 12mm x 58mm S S-LIFT, Split Rib, Straight, 19mm, 10X43mm L S-LIFT, Split Rib, Lordotic, 19mm, 14X53mm IM Interbody, Straight, 14mm x 58mm S S-LIFT, Split Rib, Straight, 19mm, 12X43mm L S-LIFT, Split Rib, Lordotic, 19mm, 16X53mm IM Interbody, Straight, 16mm x 58mm S S-LIFT, Split Rib, Straight, 19mm, 14X43mm L S-LIFT, Split Rib, Lordotic, 19mm, 10X58mm IM Interbody, Lordotic, 10mm x 38mm S S-LIFT, Split Rib, Straight, 19mm, 8X48mm L S-LIFT, Split Rib, Lordotic, 19mm, 12X58mm IM Interbody, Lordotic, 12mm x 38mm S S-LIFT, Split Rib, Straight, 19mm, 10X48mm L S-LIFT, Split Rib, Lordotic, 19mm, 14X58mm IM Interbody, Lordotic, 14mm x 38mm S S-LIFT, Split Rib, Straight, 19mm, 12X48mm L S-LIFT, Split Rib, Lordotic, 19mm, 16X58mm IM Interbody, Lordotic, 16mm x 38mm S S-LIFT, Split Rib, Straight, 19mm, 14X48mm L S-LIFT, Split Rib, Lordotic, 19mm, 10X62mm IM Interbody, Lordotic, 10mm x 43mm S S-LIFT, Split Rib, Straight, 19mm, 8X53mm L S-LIFT, Split Rib, Lordotic, 19mm, 12X62mm IM Interbody, Lordotic, 12mm x 43mm S S-LIFT, Split Rib, Straight, 19mm, 10X53mm L S-LIFT, Split Rib, Lordotic, 19mm, 14X62mm IM Interbody, Lordotic, 14mm x 43mm S S-LIFT, Split Rib, Straight, 19mm, 12X53mm L S-LIFT, Split Rib, Lordotic, 19mm, 16X62mm IM Interbody, Lordotic, 16mm x 43mm S S-LIFT, Split Rib, Straight, 19mm, 14X53mm L S-LIFT, Split Rib, Lordotic, 22mm, 10X38mm IM Interbody, Lordotic, 10mm x 48mm S S-LIFT, Split Rib, Straight, 19mm, 8X58mm L S-LIFT, Split Rib, Lordotic, 22mm, 12X38mm IM Interbody, Lordotic, 12mm x 48mm S S-LIFT, Split Rib, Straight, 19mm, 10X58mm L S-LIFT, Split Rib, Lordotic, 22mm, 14X38mm IM Interbody, Lordotic, 14mm x 48mm S S-LIFT, Split Rib, Straight, 19mm, 12X58mm L S-LIFT, Split Rib, Lordotic, 22mm, 16X38mm IM Interbody, Lordotic, 16mm x 48mm S S-LIFT, Split Rib, Straight, 19mm, 14X58mm L S-LIFT, Split Rib, Lordotic, 22mm, 10X43mm IM Interbody, Lordotic, 10mm x 53mm S S-LIFT, Split Rib, Straight, 19mm, 8X62mm L S-LIFT, Split Rib, Lordotic, 22mm, 12X43mm IM Interbody, Lordotic, 12mm x 53mm S S-LIFT, Split Rib, Straight, 19mm, 10X62mm L S-LIFT, Split Rib, Lordotic, 22mm, 14X43mm IM Interbody, Lordotic, 14mm x 53mm S S-LIFT, Split Rib, Straight, 19mm, 12X62mm L S-LIFT, Split Rib, Lordotic, 22mm, 16X43mm IM Interbody, Lordotic, 16mm x 53mm S S-LIFT, Split Rib, Straight, 19mm, 14X62mm L S-LIFT, Split Rib, Lordotic, 22mm, 10X48mm IM Interbody, Lordotic, 10mm x 58mm S S-LIFT, Split Rib, Straight, 22mm, 8X38mm L S-LIFT, Split Rib, Lordotic, 22mm, 12X48mm IM Interbody, Lordotic, 12mm x 58mm S S-LIFT, Split Rib, Straight, 22mm, 10X38mm L S-LIFT, Split Rib, Lordotic, 22mm, 14X48mm IM Interbody, Lordotic, 14mm x 58mm S S-LIFT, Split Rib, Straight, 22mm, 12X38mm L S-LIFT, Split Rib, Lordotic, 22mm, 16X48mm IM Interbody, Lordotic, 16mm x 58mm S S-LIFT, Split Rib, Straight, 22mm, 14X38mm L S-LIFT, Split Rib, Lordotic, 22mm, 10X53mm Interbody, Straight, 19mm, 8mm x 48mm S S-LIFT, Split Rib, Straight, 22mm, 8X43mm L S-LIFT, Split Rib, Lordotic, 22mm, 12X53mm Interbody, Straight, 19mm, 10mm x 48mm S S-LIFT, Split Rib, Straight, 22mm, 10X43mm L S-LIFT, Split Rib, Lordotic, 22mm, 14X53mm Interbody, Straight, 19mm, 12mm x 48mm S S-LIFT, Split Rib, Straight, 22mm, 12X43mm L S-LIFT, Split Rib, Lordotic, 22mm, 16X53mm Interbody, Straight, 19mm, 14mm x 48mm S S-LIFT, Split Rib, Straight, 22mm, 14X43mm L S-LIFT, Split Rib, Lordotic, 22mm, 10X58mm Interbody, Straight, 19mm, 16mm x 48mm S S-LIFT, Split Rib, Straight, 22mm, 8X48mm L S-LIFT, Split Rib, Lordotic, 22mm, 12X58mm Interbody, Straight, 19mm, 8mm x 53mm S S-LIFT, Split Rib, Straight, 22mm, 10X48mm L S-LIFT, Split Rib, Lordotic, 22mm, 14X58mm Interbody, Straight, 19mm, 10mm x 53mm S S-LIFT, Split Rib, Straight, 22mm, 12X48mm L S-LIFT, Split Rib, Lordotic, 22mm, 16X58mm Interbody, Straight, 19mm, 12mm x 53mm S S-LIFT, Split Rib, Straight, 22mm, 14X48mm L S-LIFT, Split Rib, Lordotic, 22mm, 10X62mm Interbody, Straight, 19mm, 14mm x 53mm S S-LIFT, Split Rib, Straight, 22mm, 8X53mm L S-LIFT, Split Rib, Lordotic, 22mm, 12X62mm Interbody, Straight, 19mm, 16mm x 53mm S S-LIFT, Split Rib, Straight, 22mm, 10X53mm L S-LIFT, Split Rib, Lordotic, 22mm, 14X62mm Interbody, Straight, 19mm, 8mm x 58mm S S-LIFT, Split Rib, Straight, 22mm, 12X53mm L S-LIFT, Split Rib, Lordotic, 22mm, 16X62mm Interbody, Straight, 19mm, 10mm x 58mm S S-LIFT, Split Rib, Straight, 22mm, 14X53mm IM Interbody, Straight, 8mm x 38mm Interbody, Straight, 19mm, 12mm x 58mm S S-LIFT, Split Rib, Straight, 22mm, 8X58mm IM Interbody, Straight, 10mm x 38mm Interbody, Straight, 19mm, 14mm x 58mm S S-LIFT, Split Rib, Straight, 22mm, 10X58mm IM Interbody, Straight, 12mm x 38mm Interbody, Straight, 19mm, 16mm x 58mm S S-LIFT, Split Rib, Straight, 22mm, 12X58mm IM Interbody, Straight, 14mm x 38mm Interbody, Straight, 19mm, 9mm x 48mm S S-LIFT, Split Rib, Straight, 22mm, 14X58mm IM Interbody, Straight, 16mm x 38mm Interbody, Straight, 19mm, 11mm x 48mm S S-LIFT, Split Rib, Straight, 22mm, 8X62mm IM Interbody, Straight, 8mm x 43mm Interbody, Straight, 19mm, 13mm x 48mm S S-LIFT, Split Rib, Straight, 22mm, 10X62mm IM Interbody, Straight, 10mm x 43mm Interbody, Straight, 19mm, 15mm x 48mm S S-LIFT, Split Rib, Straight, 22mm, 12X62mm IM Interbody, Straight, 12mm x 43mm Interbody, Straight, 19mm, 9mm x 53mm S S-LIFT, Split Rib, Straight, 22mm, 14X62mm IM Interbody, Straight, 14mm x 43mm Interbody, Straight, 19mm, 11mm x 53mm L S-LIFT, Split Rib, Lordotic, 19mm, 10X38mm IM Interbody, Straight, 16mm x 43mm Interbody, Straight, 19mm, 13mm x 53mm L S-LIFT, Split Rib, Lordotic, 19mm, 12X38mm IM Interbody, Straight, 8mm x 48mm Interbody, Straight, 19mm, 15mm x 53mm L S-LIFT, Split Rib, Lordotic, 19mm, 14X38mm IM Interbody, Straight, 10mm x 48mm Interbody, Straight, 19mm, 9mm x 58mm L S-LIFT, Split Rib, Lordotic, 19mm, 16X38mm IM Interbody, Straight, 12mm x 48mm Interbody, Straight, 19mm, 11mm x 58mm L S-LIFT, Split Rib, Lordotic, 19mm, 10X43mm IM Interbody, Straight, 14mm x 48mm Interbody, Straight, 19mm, 13mm x 58mm L S-LIFT, Split Rib, Lordotic, 19mm, 12X43mm IM Interbody, Straight, 16mm x 48mm Interbody, Straight, 19mm, 15mm x 58mm L S-LIFT, Split Rib, Lordotic, 19mm, 14X43mm IM Interbody, Straight, 8mm x 53mm L S-LIFT, Split Rib, Lordotic, 19mm, 16X43mm IM Interbody, Straight, 10mm x 53mm SI50071 Graft Block L S-LIFT, Split Rib, Lordotic, 19mm, 10X48mm IM Interbody, Straight, 12mm x 53mm SI02841 Osteophyte Shaver Indications The S-LIFT Intervertebral Body Fusion Device is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The SpineFrontier S-LIFT Intervertebral Body Fusion Device is intended to be used with supplemental spinal fixation system(s) cleared for use in the lumbar spine (example: Facet Screw Fixation). Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Sterilization The S-LIFT Intervertebral Fusion Device implants are provided nonsterile and should be stored in their original packaging until cleaned and sterilized according to the recommended guidelines listed below. Implants are single-use devices, thus do not clean or resterilize an implant that has been in contact with or contaminated by blood or other infectious substances. The manufacturer and distributor assume no responsibility for cleaning and resterilization of implants, components, or reusable instruments performed by the individual or hospital. SpineFrontier S-LIFT Intervertebral Body Fusion Devices are supplied clean and not sterile. ISO 8828 or AORN recommended practices for in-hospital sterilization to meet an SAL of 10-6 should be followed for all components. This sterilization cycle is not considered by the Food and Drug Administration to be a standard sterilization cycle. It is the end user s responsibility to use only sterilizers and accessories (such as sterilization wraps, sterilization pouches, chemical indicators, biological indicators, and sterilization cassettes) that have been cleared by the Food and Drug Administration for the selected steriliza tion cycle specifications listed: Implant Case Sterilizaton Sterilizer Type: Pre-Vacuum Min. Temperatue: 270 o F (132 o C) Exposure Time: 6 Minutes Drying Time: 50 Minutes Instrument Case Sterilizaton Sterilizer Type: Pre-Vacuum Min. Temperatue: 270 o F (132 o C) Exposure Time: 4 Minutes Drying Time: 20 Minutes S-LIFT Intervertebral Body Fusion Device Package Insert IMPORTANT NOTE TO OPERATING SURGEON Interbody fusion should only be undertaken after the surgeon has had handson training in these methods of spinal fixation, and has become thoroughly knowledgeable about spinal anatomy and biomechanics. Surgical technique manuals are available for detailed instructions on the correct use of the S-LIFT Intervertebral Body Fusion Device. The contents of these manuals are not adequate for complete instruction in the use of these systems. Even for surgeons already experienced in spinal instrumentation and interbody fusion procedures, new skills may be required that are best learned by working with an experienced surgeon or through a course of formal instruction with laboratory training. Lack of experience or expertise with these implants may result in complications. Because of the limitations imposed by anatomic considerations and modern surgical materials, implants cannot be made to last indefinitely. Limited Warranty and Disclaimer: SpineFrontier products are sold with a limited warranty to the original purchaser against defects in workmanship and materials. Any other express or implied warranties, including warranties of merchantability or illness, are hereby disclaimed. DESCRIPTION The S-LIFT Intervertebral Body Fusion Device is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The SpineFrontier S-LIFT Intervertebral Body Fusion Device is intended to be used with supplemental spinal fixation system(s) cleared for use in the lumbar spine (example: Facet Screw Fixation). The implants are provided in two configurations: straight and lordotic (8 ). Implants sizes for both configurations are offered with fixed widthes of 19mm and 22mm, lengths from 38mm 58mm (in 5mm increments) as well as 62mm, and heights from 8mm 16mm, in 2mm increments. The S-LIFT Intervertebral Body Fusion Device components are supplied nonsterile, are single use, and are fabricated from PEEK-OPTIMA LT1 with markers for radiographic visualization. PREOPERATIVE 1. ADEQUATELY INSTRUCT THE PATIENT. Postoperative care and the patient s ability and willingness to follow instructions are among the most important aspect of successful bone healing. The patient must be made aware of the limitations of the implants. The patient should understand that implants are not as strong as normal healthy bone and may loosen, bend and/or break if excessive demands are placed on it, especially in the absence of complete bone healing. Implants displaced or damaged by improper activities may experience migration of the devices and damage to nerves or blood vessels. 2. Only patients that meet the criteria described in the indications should be selected. 3. Patient condition and/or pre dispositions such as those addressed in the aforementioned contraindications should be avoided. 4. Care should be used in the handling and storage of the implant components. The implants should not be scratched or otherwise damaged. Implants and instruments should be protected during storage, especially from corrosive environments. 5. An adequate inventory of implants should be available at the time of surgery, normally a quantity in excess of what is expected to be used. 6. Since mechanical parts are involved, the surgeon should be familiar with the various components before using the equipment and should personally assemble the device to verify that all parts and necessary instruments are present before surgery begins. The S-LIFT Intervertebral Fusion Device System components (described in the DESCRIPTION section) are not be combined with the components from another manufacturer. 7. All components and instruments should be cleaned and sterilized before use. Additional sterile components should be available in case of an unexpected need. 8. Before use, instruments and implants should be visually inspected and function should be tested to assure instruments are functioning properly. If instruments are discolored, have loose screws/pins, are out of alignment, are cracked or have other irregularities, DO NOT USE! 9. Before use, all instruments are to be checked for debris, or other foreign contaminants. If any instruments or implants are observed to have any foreign debris or other contaminants, the entire convenience kit is to be returned to central processing for cleaning per listed instructions. DO NOT USE! CLEANING AND DECONTAMINATION All instruments and implants must first be cleaned according to DOC50020 S-LIFT Instrumentation Cleaning Instructions prior to sterilization and introduction into the sterile surgical field. Additionally, all instruments and implants that have been previously taken into a sterile surgical field must first be decontaminated and cleaned prior to sterilization and reintroduction into a sterile surgical field. Cleaning and disinfecting of instruments can be performed with alkali aldehyde-free solvents at higher temperatures. Cleaning and decontamination can include the use of neutral cleaners followed by a de-ionized water rinse. Note: Certain cleaning solutions such as those containing formalin, glutaraldehyde, bleach and/or alkaline cleaners may damage some devices, particularly instruments; these solutions should not be used. Also, certain instruments may require dismantling before cleaning. Refer to SpineFrontier DOC50020 S-LIFT Instrument Cleaning Instructions for further details. All devices should be positioned to allow sterilant to come in contact with all surfaces. STERILIZATION The S-LIFT Intervertebral Fusion Device implants are provided nonsterile and should be stored in their original packaging until cleaned and sterilized according to the recommended guidelines listed below. Implants are single-use devices, thus do not clean or resterilize an implant that has been in contact with or contaminated by blood or other infectious substances. The manufacturer and distributor assume no responsibility for cleaning and resterilization of implants, components, or reusable instruments performed by the individual or hospital. SpineFrontier S-LIFT Intervertebral Body Fusion Devices are supplied clean and not sterile. ISO 8828 or AORN recommended practices for in-hospital sterilization to meet an SAL of 10-6 should be followed for all components. User Sterilization Guidelines for Non-Sterile Implants All devices should be positioned to allow sterilant to come in contact with all surfaces. Care should be taken to protect implants from mechanical damage. 1. Decontamination: Saturate the surface completely with full strength disinfectant cleaner (i.e. Cavicide) and allow to remain in contact with device for 5 minutes. 2. Pre-Cleaning: Remove gross contaminants by immersing the devices in room temperature neutral ph enzymatic cleaner (i.e. Metrizyme). Scrub with appropriate soft bristle brush until visibly clean. 3. Washing: Immerse devices in ultrasonic washer/cleaner with room temperature neutral ph enzymatic cleaner and sonicate for 10 minutes. For ultrasonic cleaning follow the manufacturer s specification for suggested water level and concentration. 4. Rinsing: Thoroughly rinse the devices with deionized or distilled water. For example, a minimum of 2 minutes, three (3) times. 5. Drying: Allow devices to air dry a minimum of 50 minutes prior to inspection and sterilization preparation. 6. Preparation: After cleaning/disinfection, visually inspect the devices. Check for burrs or scraps. 7. Sterilization: STERILIZATION This sterilization cycle is not considered by the Food and Drug Administration to be a standard sterilization cycle. It is the end user s responsibility to use only sterilizers and accessories (such as sterilization wraps, sterilization pouches, chemical indicators, biological indicators, and sterilization cassettes) that have been cleared by the Food and Drug Administration for the selected steriliza tion cycle specifications listed below: IMPLANT CASE: Method Cycle Temperature Exposure Time Dry Time Steam Pre-Vacuum 270 F (132 C) 6 Minutes 50 minutes INSTRUMENT AND ACCESSORY CASE: Method Cycle Temperature Exposure Time Dry Time Steam Pre-Vacuum 270 F (132 C) 4 Minutes 20 minutes INDICATIONS The S-LIFT Intervertebral Body Fusion Device is a spinal intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The SpineFrontier S-LIFT Intervertebral Body Fusion Device is intended to be used with supplemental spinal fixation system(s) cleared for use in the lumbar spine (example: Facet Screw Fixation). Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. CONTRAINDICATIONS Use of implants is contraindicated when there is active systemic infection, infection localized to the site of the proposed implantation, prior fusion at the level(s) to be treated, or when the patient has demonstrated allergy or foreign body sensitivity to any of the implant materials. Severe osteoporosis may prevent adequate fixation and thus preclude the use of this or any other orthopaedic implants. Patients with severe obesity, osteopenia, or degenerative diseases may place excessive stresses on bone and implants and may be at higher risk of implant failure. Conditions that reduce the likelihood of successful fusion, such as radio- or chemotherapy for cancer, kidney dialysis, or osteopenia are relative contraindications. The decision whether to use these devices in such conditions must be made by the physician taking into account the risks versus the benefits to the patient. Use of these implants is relatively contraindicated in patients whose activity, mental capacity, mental illness, alcoholism, drug abuse, occupation, lifestyle may interfere with their ability to follow post operative restrictions and who may place undue stresses on the implant during bony healing and may be of higher risk of implant failure. PATIENT POSTOPERATIVE ACTIVITIES The surgeon should inform the patient of the following postoperative activities: 1. The surgeon should inform the patient of the seriousness of the procedure performed and the limitation of the device implanted. The surgeon should also instruct the patient on how to properly recovery during the fusing process (ie. range of motion, limiting physical activities, etc.) 2. The surgeon should instruct the patient on the amount of time after surgery of any weight bearing activities. Weight bearing activities perform before fusion occurs may cause some of the following: implant expulsion,breaking of the implant, prevent proper healing/non-union 3. The patient should be immobilized until a fusion occurs. If the patient is not properly immobilized this could delay healing which could lead to non-union, implant expulsion, implant breakage, etc. 4. Patients should be instructed not to smoke, consume alcohol, or consume non steroidals and aspirin, as determined by the surgeon. Patients should follow all surgeon postoperative activities and follow ups. 5. Implant should be revised or removed if appropriate for the following conditions: Non-union, pseudarthrosis, fractured implant, if the implant expels from the disc space, or if the surgeon determines the implant needs to be revised or removed for other reasons. Following are specific warnings, precautions and adverse affects which should be understood by the surgeon and explained to the patient. These warnings do not include all adverse effects which can occur with surgery in general, but are important considerations particular to devices such as internal fixation implants and interbody fusion implants. General surgical risks should be explained to the patient prior to surgery. WARNINGS, PRECAUTIONS AND ADVERSE EFFECTS CONCERNING SPINAL FIXATION IMPLANTS WARNINGS 1. CORRECT SELECTION OF THE IMPLANT IS EXTREMELY IMPORTANT. The potential for satisfactory fixation is increased by the selection of the proper size, shape, and design of the implant. While proper selection can help minimize risks, the size and shape of human bones present limitations on the size, shape and strength of implants. Internal fixation devices cannot withstand activity levels equal to those placed on normal healthy bone. No implant can be expected to withstand indefinitely the unsupported stress of full weight bearing. 2. IMPLANTS CAN BREAK WHEN SUBJECTED TO THE INCREASED LOADING ASSOCIATED WITH DELAYED UNION OR NON-UNION. Internal fixation appliances are load sharing devices which are used to obtain an alignment until normal healing occurs. If healing is delayed, or does not occur, the implant may eventually break due to material fatigue The degree or success of union, loads produced by weight bearing, and activity levels will, among other conditions, dictate the longevity of the implant. Notches, scratches or bending of the implant during the course of surgery may also contribute to early failure. Patients should be fully informed of the risks of implant failure. 3. PATIENT SELECTION. In selecting patients for internal fixation devices, the following factors can be of extreme importance to the eventual success of the procedure: a. Previous Spinal Surgery: Patients with previous spinal surgery at the level(s) to be treated may have different clinical outcomes compared to those without a previous surgery. b. The patient s weight. An overweight or obese patient can produce loads on the device which can lead to failure of the appliance and the operation. c. The patient s occupation or activity. If the patient is involved in an occupation or activity that includes heavy lifting, muscle strain twisting, repetitive bending, stooping, running, substantial walking, or manual labor, he/she should not return to these activities until the bone is fully healed. Even with full healing the patient may not be able to return to these activities successfully. d. A condition of senility, mental illness, alcoholism, or drug abuse. These conditions, among others, may cause the patient to ignore certain necessary limitations and precautions in the use of the appliance, leading to implant failure or other complications. e. Certain degenerative diseases. In some cases, the progression of degenerative disease may be so advanced at the time of implantation that it may substantially decrease the expected useful life of the appliance For such cases, orthopedic devices can only be considered a delaying technique or temporary remedy. f. Foreign body sensitivity. Where material allergy or sensitivity is suspected, appropriate tests (such as skin sensitivity testing) should be made prior to implant selection or use. The surgeon is advised that no pre-operative test can completely exclude the possibility of sensitivity or allergic reaction Patients can develop sensitivity or allergy after implants have been in the body for a period of time. g. Smoking. Smoking has been shown to cause diffuse degeneration of intervertebral discs. Progressive degeneration of adjacent segments caused by smoking can lead to late clinical failure (recurring pain) even after successful fusion and initial clinical improvement. 4. MAGNETIC RESONANCE (MR). The S-LIFT Intervertebral Body Fusion Device has not been evaluated for safety and compatibility in the MR environment. The S-LIFT Intervertebral Body Fusion Device has not been tested for heating or migration in the MR environment. PRECAUTIONS 1. SURGICAL IMPLANTS MUST NEVER BE REUSED. An explanted implant should never be reimplanted. Even though the device appears undamaged, it may have small defects and internal stress patterns which may lead to early breakage. 2. CORRECT HANDLING OF THE IMPLANT IS EXTREMELY IMPORTANT. Implants: Contouring of implants should only be done with proper equipment. The operating surgeon should avoid notching, scratching or reverse bending of the implants when contouring. Alterations will produce defects in surface finish and internal stresses which may become the focal point for eventual breakage of the implant. Bending of screws will significantly decrease the fatigue life and may cause failure. 3. ADEQUATELY INSTRUCT THE PATIENT. Postoperative care and the patient s ability and willingness to follow instructions are among the most important aspects of successful bone healing. The patient must be made aware of the limitations of the implants. The patient should be encouraged to ambulate to tolerance as soon as possible after surgery, and instructed to limit and restrict lifting and twisting motions and any type of sports participation until the bone is healed. The patient should understand that implants are not as strong as normal healthy bone and may loosen, bend and/or break if excessive demands are placedon it, especially in the absence of complete bone healing. Implants displaced or damaged by improper activities may experience migration of the devices and damage to nerves or blood vessels. POSSIBLE ADVERSE EFFECTS WITH THE S-LIFT Intervertebral Body Fusion Device This list may not include all complications caused by the surgical procedure itself. 1. Nonunion, delayed union. 2. Bending or fracture of implant. Loosening of the implant. 3. Material sensitivity or allergic reaction to a foreign body. 4. Infection, early or late. 5. Decrease in bone density due to stress shielding. 6. Pain, discomfort, or abnormal sensations due to the presence of the device. 7. Nerve damage due to surgical trauma or presence of the device Neurological difficulties including bowel and/or bladder dysfunction, impotence, retrograde ejaculation, radicular pain, tethering of nerves in scar tissue, muscle weakness, and paresthesia. 8. Vascular damage could result in catastrophic or fatal bleeding. Malpositioned implants adjacent to large arteries or veins could cause erosion of these vessels and catastrophic bleeding in the late post operative period. 9. Dural tears experienced during surgery could result in need for further surgery for dural repair, a chronic CSF leak or fistula, and possible meningitis. 10. Bursitis. 11. Paralysis. 12. Death. 13. Spinal cord impingement or damage. 14. Fracture of bony structures. 15. Reflex sympathetic dystrophy. 16. Degenerative changes or instability in segments adjacent to fused vertebral levels. IF MORE THAN TWO YEARS HAVE ELAPSED BETWEEN THE DATE OF ISSUE/ REVISION AND THE DATE OF CONSULTATION, CONTACT SPINEFRONTIER, FOR CURRENT INFORMATION AT: SpineFrontier, Inc., 500 Cummings Center, Suite 3500, Beverly, MA P: DOC50001.RevD 25 S-LIFT Surgical Technique S-LIFT Surgical Technique 26