Technique Guide MAXIMUM ACCESS SURGICAL PLATFORM

Transcription

1 Technique Guide MAXIMUM ACCESS SURGICAL PLATFORM

2 MAXIMUM ACCESS SURGICAL PLATFORM CONTENTS Preface 1 SpheRx II Anterior Technique Guide 2 Equipment Requirements 2 Patient Positioning and O.R. Setup 2 Staple Insertion 2 Pilot Hole Preparation 4 Screw Insertion 6 Distraction 7 Rod Insertion 8 Rod Compression 10 Cross Connector Insertion 11 Device Removal 12 SpheRx II Anterior System 13 Catalog 21 Instructions for Use 24

3 PREFACE Fellow Colleagues: Among the advancements made in the past decade of improving the way spine surgery is performed has been the validation of minimally disruptive options to traditional surgical approaches. The results are reduced morbidity, shortened hospital stay, and quicker return to normal activities. However, the surgical approach options for performing thoracolumbar corpectomies have remained limited and are largely relegated to an open thoracotomy approach. This is due to the need for sufficient visualization of the surgical site to accomplish a direct decompression, corpectomy, vertebral body replacement, and fixation. The morbidity associated with a thoracotomy approach is often equal to the pathology it is intended to treat an unfortunate, unavoidable consequence. Reducing exposure requirements and, in turn, patient morbidity inspired the development of the suite of XLIF Corpectomy products. A fundamental advantage to the XLIF Corpectomy approach is the ability to utilize a conventional technique in order to perform a decompression and corpectomy through a significantly reduced exposure. SpheRx II Anterior implants and instrumentation were developed to work in conjunction with the NuVasive MaXcess Retractor system to provide adequate exposure to the surgical site while significantly reducing incision length. Among the notable design features of the SpheRx II Anterior system are: Staple designs contour to the retractor blades, as well as the lateral vertebral body Multi-angled instruments facilitate a wide range of exposures Implant delivery instruments allow easy passage and placement of implants through the XLIF approach Compression and distraction options are compatible with the MaXcess system I trust that you will recognize the novel design of the SpheRx II Anterior system and appreciate the numerous benefits the XLIF Corpectomy procedure will have on patient outcomes. Cordially, Christopher J. Chittum, M.D. Spartanburg Neurosurgical Institute Spartanburg, South Carolina USA 1

4 MAXIMUM ACCESS SURGICAL PLATFORM SPHERX II ANTERIOR TECHNIQUE GUIDE EQUIPMENT REQUIREMENTS SpheRx II Anterior Instruments Tray One SpheRx II Anterior Instruments Tray Two SpheRx II Anterior Implants Tray Optional: NVM5 System For XLIF Corpectomy equipment requirements, refer to the XLIF Corpectomy Surgical Technique For a complete list of intended uses, indications, device description, contraindications, warnings, and precautions, please refer to the Instructions for Use (IFU) in the back of this technique guide. NVM5 ANESTHESIA PATIENT POSITIONING AND O.R. SETUP The patient will be placed on a radiolucent, bendable surgical table in a direct lateral decubitus (90 ) position, with the MaXcess Retractor positioned over the operative level (Fig. 1). This is the same position established during the corpectomy and reconstruction procedure, using the NuVasive expandable cage. Prior to initiating the SpheRx II Anterior procedure, reconfirm a true A/P fluoroscopy image of the operative site with the C-arm at 0 and a true lateral image with the C-arm at 90. Ensure the MaXcess Retractor is positioned between the middle and the anterior third of the vertebral body with clear access to the superior and inferior vertebral bodies for instrument and implant placement. It may be necessary to increase the aperture of the MaXcess Retractor or to angle the blade(s) to obtain sufficient exposure. FLUORO FLUORO MONITORS (Fig. 1) STEP 1: STAPLE INSERTION Vertebral body staples may be inserted using either the Staple Guide or the Staple Inserter. Staple insertion, pilot hole preparation, and screw insertion should all be completed on one vertebral segment before adjusting the MaXcess Retractor and completing insertion at the second level. Staples are color-coded by size (small, medium, or large) and intended position (superior or inferior) (Fig. 2), and should always be used as indicated. Select the appropriate size staple, based on patient anatomy; generally, the largest staple that will fit the vertebral body should be used. SUPERIOR Small: Magenta Medium: Gold Large: Blue POSTERIOR STAPLE SIZES/COLOR CODING INFERIOR Small: Light Blue Medium: Green Large: Purple * Assumes a left side approach. Orientation is reversed for right side approach. ANTERIOR 2 ENDPLATE (Fig. 2)

5 SPHERX II ANTERIOR TECHNIQUE GUIDE STEP 1: STAPLE INSERTION (CONT.) Engage the corresponding Staple Guide, or Staple Inserter, to the staple by inserting the Staple Inserter Retainer through the shaft and threading the tip into the staple (Fig. 3). Prior to impaction, verify the A on the staple or Staple Guide is positioned anterior and the P is positioned posterior, with the bold laser mark perpendicular to the endplate and the handle positioned over the corpectomy defect. Impact the staple until the surface is flush with the vertebral body (Fig. 4). Single Hole Staple (Optional) Single Hole Staples may be used if a single rod is desired, or for greater freedom over screw trajectory. Single Hole Staples may be inserted using the Single Hole Staple Inserter. Engage the Single Hole Staple by threading the Single Hole Staple Inserter into the interior of the staple hole. The Single Hole Staple Inserter incorporates a short Awl tip, which will perforate the cortex of the vertebral body during staple insertion. (Fig. 3) (Fig. 4) 3

6 MAXIMUM ACCESS SURGICAL PLATFORM SPHERX II ANTERIOR TECHNIQUE GUIDE STEP 2: PILOT HOLE PREPARATION Staple Guide The Staple Guide will direct the posterior screw 8 anterior and the anterior screw 0 in the axial plane (Fig. 5). Prior to pilot hole preparation, insert a Guide Sleeve into the posterior barrel of the Staple Guide, ensuring the distal tip is fully engaged within the barrel. Pilot holes may be created using an Awl, Drill, or Tap. Insert the instrument into the Guide Sleeve, and create a pilot hole to the desired depth, using fluoroscopy for guidance (Fig. 6). Screw length may be determined by the intersection of the Guide Sleeve and the depth markings on the shaft, or by using the Depth Gauge after instrument and Staple Guide removal. Repeat the preparation procedure for the anterior screw, and unthread the Staple Inserter Retainer to remove the Staple Guide. 0 8 (Fig. 5) (Fig. 6) 4

7 SPHERX II ANTERIOR TECHNIQUE GUIDE STEP 2: PILOT HOLE PREPARATION (CONT.) Staple Inserter Engage the Staple Inserter to the staple, using the Staple Inserter Retainer, and impact the staple into the vertebral body with the A positioned anterior and the P positioned posterior. Ensure the staple is flush with the vertebral body, unthread the Staple Inserter Retainer, and remove the Staple Inserter. The Staple Tamp may be used if additional staple impaction is required. Create pilot holes through the staple, using the Awl, Drill, or Tap, ensuring the posterior hole is angled approximately 8 anterior and the anterior hole is 0 in the axial plane (Fig. 7). Fluoroscopy should always be used throughout pilot hole preparation to monitor instrument depth and ensure the anterior and posterior elements are avoided. The Depth Gauge may be used after instrument removal to determine screw length. (Fig. 7) Self-Centering Awl (Optional) The Self-Centering Awl is designed to create pilot holes with the proper axial trajectories when engaged with either the staple hole or Staple Guide barrels. Prior to pilot hole preparation, depress the button on the depth stop and move to the desired depth, ensuring the depth stop positively clicks into position. Insert the tip of the Self- Centering Awl sleeve into the staple or Staple Guide barrel, ensuring the tip is securely seated. Using A/P and lateral fluoroscopy for guidance, push the Awl into the vertebral body until the depth stop is flush with the Awl shaft (Fig. 8). Screw length may be determined by the final position of the depth stop or by using the Depth Gauge. (Fig. 8) 5

8 MAXIMUM ACCESS SURGICAL PLATFORM SPHERX II ANTERIOR TECHNIQUE GUIDE STEP 3: SCREW INSERTION The staples are designed to accommodate either fixed or polyaxial screws. The selected screw type must always be used with the corresponding Screwdriver design. Insert the tip of the Screwdriver into the head of the screw (Fig. 9) and secure by threading the outer sleeve into the tulip (Fig. 10). Insert the screw into the prepared pilot hole until the head is fully seated onto the staple. Wherever possible, screws should extend approximately 2mm beyond the distal cortex to achieve bicortical fixation (Fig. 11). Prior to repeating staple insertion on the adjacent level, ensure the screw heads are positioned with the rod slots aligned longitudinally to facilitate rod introduction. Repeat staple insertion, pilot hole preparation, and screw insertion on the adjacent level. (Fig. 9) (Fig. 10) (Fig. 11) 6

9 SPHERX II ANTERIOR TECHNIQUE GUIDE STEP 4: DISTRACTION (OPTIONAL) Distraction may be applied prior to rod insertion if a fixed vertebral body replacement (VBR) device is being used. Insert the Distractor Arms into the ends of the Compressor/ Distractor, ensuring they are securely engaged (Fig. 12). Place the tips of the Distractor Arms into the anterior screw heads, and secure into position with lockscrews, using the Lockscrew Starter (Fig. 13). Prior to distraction, position the switch on the body of the Compressor/Distractor to D (distraction) (Fig. 14a). Rotate the handle clockwise until the desired level of distraction is achieved (Fig. 14). Note The Distractor may be used as needed when working through MaXcess to provide a lower profile instrument. (Fig. 12) (Fig. 14a) (Fig. 13) (Fig. 14) 7

10 MAXIMUM ACCESS SURGICAL PLATFORM SPHERX II ANTERIOR TECHNIQUE GUIDE STEP 5: ROD INSERTION Insert the tips of the Rod Measurement Tool into the posterior screw heads; the measured length on the Rod Measurement Tool will indicate the distance between the centers of the screws (Fig. 15). Add approximately 10mm to the measured length to accommodate for overhang of the rod beyond the screws. Grasp the selected rod with the Pivoting Rod Holder, and angle the rod vertically in line with the Pivoting Rod Holder. Insert the rod vertically through the MaXcess exposure, and position the distal end into the first posterior screw head. Push the rod into the adjacent posterior screw, allowing the tip of the Pivoting Rod Holder to articulate (Fig. 16). (Fig. 15) (Fig. 16) 8

11 SPHERX II ANTERIOR TECHNIQUE GUIDE STEP 5: ROD INSERTION (CONT.) If the rod does not fully seat into the screw heads, the Rod Pusher may be used to manipulate the rod into the desired position. Place a lockscrew onto the Lockscrew Starter, and thread a lockscrew into both screw heads (Fig. 17) prior to removing the Pivoting Rod Holder. Repeat rod insertion on the anterior screws. If compression is not required, place the Counter-Torque over the first posterior screw and insert the Lockscrew Driver, with the Torque T-handle engaged (Fig. 18). Ensure the tip of the Lockscrew Driver is fully engaged with the lockscrew, and turn the Torque T-handle clockwise until an audible click is heard. Repeat final tightening on the remaining screws. (Fig. 17) (Fig. 18) 9

12 MAXIMUM ACCESS SURGICAL PLATFORM SPHERX II ANTERIOR TECHNIQUE GUIDE STEP 6: ROD COMPRESSION (OPTIONAL) If compression is required, ensure the lockscrews are finger tight within the screw heads. Fully tighten the superior or inferior lockscrew on the posterior rod, and insert the Compressor around the outside of the screw heads. Compress the segment until the desired level of compression is achieved, and tighten the remaining lockscrew to hold position on the rod. Repeat compression, as required, on the anterior rod, and perform final tightening on the remaining screws. Optional If the distance between the screw heads is greater than the maximum distance allowed by the Compressor, the Temporary Compressor Block may be used. Prior to inserting the Temporary Compressor Block, fully tighten either the superior or inferior lockscrew, leaving the remaining lockscrew finger tight. Attach the Temporary Compressor Inserter to the Temporary Compressor Block by pulling up on the flange at the top of the shaft and placing the tip of the Inserter over the lockscrew on the Temporary Compressor Block (Figs. 19, 19a). Place the Temporary Compressor Block onto the center of the rod and secure into position by turning the T-handle clockwise (Fig. 20). Place the Compressor around the outsides of the Temporary Compressor Block and the unsecured screw head, and compress the segment (Fig. 21). Tighten the unsecured lockscrew to hold position on the rod, and remove the Compressor prior to performing final tightening, using the Counter-Torque. Remove the Temporary Compressor Block by attaching the Temporary Compressor Inserter (as described previously) and rotating the T-handle counterclockwise. (Fig. 19) (Fig. 19a) (Fig. 20) (Fig. 21) 10

13 SPHERX II ANTERIOR TECHNIQUE GUIDE STEP 7: CROSS CONNECTOR INSERTION Determine the appropriate cross connector length by placing a Fixed Connector Template over the rods, ensuring the rod slots are fully engaged with both rods. With the measured length cross connector remaining in the caddy, engage the Cross Connect Inserter by pulling up on the flange at the top of the shaft and placing the tip over the cross connector lockscrew. Ensure both tabs on the Cross Connect Inserter are engaged with the slots on the sides of the cross connector prior to releasing the flange (Fig. 22). With the Cross Connect Inserter secured to the cross connector, place the connector onto the rods, ensuring the rod slots are fully seated onto both rods. Engage the Counter-Torque Tool to the top of the Cross Connect Inserter, and insert the Cross Connect Driver to engage the lockscrew. Tighten the lockscrew, using the Transverse Connector Torque T-handle until an audible click is heard (Fig. 23). Pull up on the Cross Connect Inserter flange, and remove the instrument from the cross connector. Remove the MaXcess Retractor to complete the procedure. (Fig. 22) FINAL CONSTRUCT (Fig. 23) 11

14 MAXIMUM ACCESS SURGICAL PLATFORM SPHERX II ANTERIOR TECHNIQUE GUIDE DEVICE REMOVAL Step 1: Lockscrew Removal Place the Counter-Torque over the first screw head, and insert the Lockscrew Driver to engage the lockscrew. During removal, a standard handle should always be used on the Lockscrew Driver rather than the Torque T-handle. Rotate the handle of the Lockscrew Driver counterclockwise until the lockscrew is loosened, but not fully unthreaded from the screw head. Repeat this step for the remaining lockscrews until all lockscrews are loosely retained within the screw heads. Remove the Counter- Torque and Lockscrew Driver, and use the Lockscrew Starter to remove each lockscrew, ensuring the lockscrew is retained on the Lockscrew Starter. Step 2: Rod/Cross Connector Removal Grasp either the anterior or superior rod, using the Pivoting Rod Holder to remove the rod(s) and cross connector. Step 3: Screw Removal Insert the tip of the appropriate Screwdriver (fixed or polyaxial) into the head of the screw and secure into position by threading the outer sleeve into the tulip (refer to Figs. 8 and 9). Remove the screw from the vertebral body. Remove the remaining screws, using the appropriate Screwdriver design. Step 4: Staple Removal Engage the Staple Inserter into the holes in the center of the staple, and thread the Staple Inserter Retainer through the shaft into the staple to secure position. Remove the staple by pulling up on the Staple Inserter until the staple is released from the vertebral body. Repeat removal procedure on the remaining staple to complete construct removal. 12

15 SPHERX II ANTERIOR SYSTEM SPHERX II ANTERIOR INSTRUMENTS (TRAY ONE) SPHERX II ANTERIOR INSTRUMENTS (TRAY ONE) STAPLE INSERTER STAPLE GUIDE SINGLE HOLE STAPLE INSERTER STAPLE INSERTER RETAINER SELF-CENTERING AWL GUIDE SLEEVE 13

16 MAXIMUM ACCESS SURGICAL PLATFORM SPHERX II ANTERIOR SYSTEM SPHERX II ANTERIOR INSTRUMENTS (TRAY ONE) AWL ANGLED AWL LONG AWL DRILL TAP, 4.5mm TAP, 5.5mm TAP, 6.5mm TAP, 7.5mm 14

17 SPHERX II ANTERIOR SYSTEM SPHERX II ANTERIOR INSTRUMENTS (TRAY ONE) DEPTH GAUGE FIXED SCREWDRIVER POLYAXIAL SCREWDRIVER STAPLE TAMP RATCHETING STRAIGHT HANDLE QUICK CONNECT T-HANDLE SCREW ADJUSTER PIVOTING ROD HOLDER 15

18 MAXIMUM ACCESS SURGICAL PLATFORM SPHERX II ANTERIOR SYSTEM SPHERX II ANTERIOR INSTRUMENTS (TRAY TWO) SPHERX II ANTERIOR INSTRUMENTS (TRAY TWO) ROD PUSHER LOCKSCREW STARTER, STRAIGHT LOCKSCREW DRIVER FIXED CONNECTOR TEMPLATE ROD MEASUREMENT TOOL COUNTER-TORQUE 16

19 SPHERX II ANTERIOR SYSTEM SPHERX II ANTERIOR INSTRUMENTS (TRAY TWO) COUNTER-TORQUE TOOL TORQUE T-HANDLE COMPRESSOR DISTRACTOR TEMPORARY COMPRESSOR INSERTER TRANSVERSE CONNECTOR TORQUE T-HANDLE DISTRACTOR ARMS TEMPORARY COMPRESSOR BLOCK COMPRESSOR TIP 17

20 MAXIMUM ACCESS SURGICAL PLATFORM SPHERX II ANTERIOR SYSTEM SPHERX II ANTERIOR INSTRUMENTS (TRAY TWO) CROSS CONNECT INSERTER CROSS CONNECT DRIVER LOCKSCREW STARTER GUIDE ROD BENDER 18

21 S P H E R X II ANTER IO R S YS TEM S P H E R X II ANTER IO R IMP LA NTS S PH ERX II AN TE RIOR IMPL AN TS TRAY I N F E RI O R S TAPLE, S M ALL IN F E RIOR STAPL E, ME DIUM IN F E RIOR STAPL E, L ARGE S UP E RI O R S TAPLE, S M ALL SUPE RIOR STAPL E, ME DIUM SUPE RIOR STAPL E, L ARGE S I N GL E HO LE S TAPLE, S M ALL SIN GL E HOL E STAPL E, ME DIUM SIN GL E HOL E STAPL E, L ARG E WA SH ER, S M ALL WASHE R, ME DIUM WASHE R, L ARGE 19

22 MAXIMUM ACCESS SURGICAL PLATFORM SPHERX II ANTERIOR SYSTEM SPHERX II ANTERIOR IMPLANTS POLYAXIAL SCREW, 5.5mm FIXED SCREW, 5.5mm POLYAXIAL SCREW, 6.5mm FIXED SCREW, 6.5mm POLYAXIAL SCREW, 7.5mm FIXED SCREW, 7.5mm SPHERX II ANTERIOR FIXED CONNECTOR SPHERX II LOCKSCREW CONVENTIONAL ROD 20

23 CATALOG SPHERX II ANTERIOR INSTRUMENTS (TRAY ONE) SPHERX II ANTERIOR INSTRUMENTS (TRAY TWO) DESCRIPTION CATALOG # Staple Inserter Inferior Staple Guide, Small Inferior Staple Guide, Medium Inferior Staple Guide, Large Superior Staple Guide, Small Superior Staple Guide, Medium Superior Staple Guide, Large Single Hole Staple Inserter Staple Inserter Retainer Self-Centering Awl Guide Sleeve Awl Angled Awl Long Awl mm Drill mm Tap mm Tap mm Tap mm Tap Ratcheting Straight Handle Quick Connect T-handle Depth Gauge Fixed Screwdriver Polyaxial Screwdriver Screw Adjuster Staple Tamp Pivoting Rod Holder SpheRx II Anterior System (Instrument Tray One, Lid) SpheRx II Anterior System (Instrument Tray One, Insert One) SpheRx II Anterior System (Instrument Tray One, Insert Two) SpheRx II Anterior System (Instrument Tray One, Base) SpheRx IFU DESCRIPTION CATALOG # Rod Pusher Rod Measurement Tool Lockscrew Starter Guide/Counter-Torque Lockscrew Starter, Straight Lockscrew Driver Counter-Torque Counter-Torque Tool Torque T-handle Compressor Distractor Compressor/Distractor Distractor Arms Temporary Compressor Block Temporary Compressor Inserter Transverse Connector Torque T-handle Fixed Connector Template, 12mm Fixed Connector Template, 13-14mm Fixed Connector Template, 15-16mm Fixed Connector Template, 17-18mm Fixed Connector Template, 19-20mm Fixed Connector Template, 21-22mm Fixed Connector Template, 23-24mm Cross Connect Inserter Cross Connect Driver Compressor Tip Compressor Tip Lockscrew Starter Guide Rod Bender SpheRx II Anterior System (Instrument Tray Two, Lid) SpheRx II Anterior System (Instrument Tray Two, Insert One) SpheRx II Anterior System (Instrument Tray Two, Insert Two) SpheRx II Anterior System (Instrument Tray Two, Base) SpheRx IFU

24 MAXIMUM ACCESS SURGICAL PLATFORM CATALOG SPHERX II ANTERIOR IMPLANTS SPHERX II ANTERIOR IMPLANTS DESCRIPTION CATALOG # Staple Caddy Staple Caddy Lid Single Hole Staple Caddy Single Hole Staple Caddy Lid Washer Caddy Washer Caddy Lid Cross Connector Caddy Cross Connector Caddy Lid Lockscrew Caddy Lockscrew Caddy Lid Polyaxial Screw Caddy Fixed Screw Caddy Inferior Staple, Small Inferior Staple, Medium Inferior Staple, Large Superior Staple, Small Superior Staple, Medium Superior Staple, Large Single Hole Staple, Small Single Hole Staple, Medium Single Hole Staple, Large Washer, Small Washer, Medium Washer, Large x 25mm Polyaxial Screw x 30mm Polyaxial Screw x 35mm Polyaxial Screw x 40mm Polyaxial Screw x 45mm Polyaxial Screw x 50mm Polyaxial Screw x 30mm Polyaxial Screw x 35mm Polyaxial Screw x 40mm Polyaxial Screw x 45mm Polyaxial Screw x 50mm Polyaxial Screw x 30mm Polyaxial Screw x 35mm Polyaxial Screw x 40mm Polyaxial Screw x 45mm Polyaxial Screw x 50mm Polyaxial Screw DESCRIPTION CATALOG # 5.5 x 25mm Fixed Screw x 30mm Fixed Screw x 35mm Fixed Screw x 40mm Fixed Screw x 45mm Fixed Screw x 50mm Fixed Screw x 55mm Fixed Screw x 30mm Fixed Screw x 35mm Fixed Screw x 40mm Fixed Screw x 45mm Fixed Screw x 50mm Fixed Screw x 55mm Fixed Screw x 60mm Fixed Screw x 30mm Fixed Screw x 35mm Fixed Screw x 40mm Fixed Screw x 45mm Fixed Screw x 50mm Fixed Screw x 55mm Fixed Screw SpheRx II Anterior Fixed Connector - 12mm SpheRx II Anterior Fixed Connector - 13mm SpheRx II Anterior Fixed Connector - 14mm SpheRx II Anterior Fixed Connector - 15mm SpheRx II Anterior Fixed Connector - 16mm SpheRx II Anterior Fixed Connector - 17mm SpheRx II Anterior Fixed Connector - 18mm SpheRx II Anterior Fixed Connector - 19mm SpheRx II Anterior Fixed Connector - 20mm SpheRx II Anterior Fixed Connector - 21mm SpheRx II Anterior Fixed Connector - 22mm

25 CATALOG SPHERX II ANTERIOR IMPLANTS DESCRIPTION CATALOG # SpheRx II Lockscrew mm Conventional Rod mm Conventional Rod mm Conventional Rod mm Conventional Rod mm Conventional Rod mm Conventional Rod mm Conventional Rod mm Conventional Rod mm Conventional Rod mm Conventional Rod mm Conventional Rod mm Conventional Rod mm Conventional Rod mm Conventional Rod mm Conventional Rod mm Conventional Rod mm Conventional Rod mm Conventional Rod mm Conventional Rod mm Conventional Rod mm Conventional Rod mm Conventional Rod mm Conventional Rod mm Conventional Rod mm Conventional Rod mm Conventional Rod SpheRx II Anterior System (Implant Tray, Lid) SpheRx II Anterior System (Implant Tray, Insert One) SpheRx II Anterior System (Implant Tray, Insert Two) SpheRx II Anterior System (Implant Tray, Base) SpheRx IFU

26 MAXIMUM ACCESS SURGICAL PLATFORM INSTRUCTIONS FOR USE DESCRIPTION The NuVasive SpheRx Spinal System consists of a series of polyaxial screws, fixed axis screws, rods, lock screws, hooks, and transverse connectors manufactured from Ti-6Al-4V per ASTM F-136 and ISO INDICATIONS When used as a pedicle screw fixation system, the NuVasive SpheRx Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the posterior thoracic, lumbar, and sacral spine: 1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) 2. Degenerative spondylolisthesis with objective evidence of neurologic impairment 3. Fracture 4. Dislocation 5. Scoliosis 6. Kyphosis 7. Spinal tumor and/or 8. Failed previous fusion (pseudoarthrosis) The NuVasive SpheRx Spinal System is also indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint in skeletally mature patients receiving fusion by autogenous bone graft, having the device fixed or attached to the lumbar and sacral spine (L3 to sacrum), with removal of the implants after attainment of a solid fusion 1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) 2. Spinal stenosis 3. Spondylolisthesis 4. Spinal deformities 5. Fracture 6. Pseudoarthosis 7. Tumor resection and/or 8. Failed previous fusion CONTRAINDICATIONS Contraindications include but are not limited to: 1. Infection, local to the operative site. 2. Signs of local inflammation. 3. Patients with known sensitivity to the materials implanted. 4. Patients who are unwilling to restrict activities or follow medical advice. 5. Patients with inadequate bone stock or quality. 6. Patients with physical or medical conditions that would prohibit beneficial surgical outcome. 7. Use with components of other systems. 8. Reuse or multiple use. 9. Any case not described in the indications. POTENTIAL ADVERSE EVENTS AND COMPLICATIONS As with any major surgical procedures, there are risks involved in orthopedic surgery. Infrequent operative and postoperative complications known to occur include: early or late infection which may result in the need for additional surgeries; damage to blood vessels; spinal cord or peripheral nerves, pulmonary emboli; loss of sensory and/or motor function; impotence; permanent pain and/or deformity. Rarely, some complications may be fatal. WARNINGS AND PRECAUTIONS The subject device is intended for use only as indicated. The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown. The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient. When used as a pedicle screw system, this device system is intended only for grade 3 or 4 spondylolisthesis at the fifth lumbar - first sacral vertebral (L5-S1) vertebral joint. The screws of this device system are not intended for insertion into the pedicles to facilitate spinal fusions above the L5-S1 joint. Benefit of spinal fusions utilizing any pedicle screw fixation system has not been adequately established in patients with stable spines. Potential risks identified with the use of this device system, which may require additional surgery, include: device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, and vascular or visceral injury. Correct selection of the implant is extremely important. The potential for success is increased by the selection of the proper size of the implant. While proper selection can minimize risks, the size and shape of human bones present limitations on the size and strength of implants. Metallic internal fixation devices cannot withstand the activity levels and/or loads equal to those placed on normal, healthy bone. These devices are not designed to withstand the unsupported stress of full weight or load bearing alone. Caution must be taken due to potential patient sensitivity to materials. Do not implant in patients with known or suspected sensitivity to the aforementioned materials. These devices can break when subjected to the increased load associated with delayed union or non-union. Internal fixation appliances are load-sharing devices that hold bony structures in alignment until healing occurs. If healing is delayed, or does not occur, the implant may eventually loosen, bend, or break. Loads on the device produced by load bearing and by the patient s activity level will dictate the longevity of the implant. Corrosion of the implant can occur. Implanting metals and alloys in the human body subjects them to a constantly changing environment of salts, acids, and alkalis, which can cause corrosion. Placing dissimilar metals in contact with each other can accelerate the corrosion process, which in turn, can enhance fatigue fractures of implants. Consequently, every effort should be made to use compatible metals and alloys in conjunction with each other. Care should be taken to insure that all components are ideally fixated prior to closure. All implants should be used only with the appropriately designated instrument (Reference Surgical Technique). Bent or kinked K-wires should not be used due to potential K-wire migration during instrument or implant passage. The Screw Insulator or other appropriate insulation should always be used during screw insertion with NVM5. Instruments and implants are not interchangeable between SpheRx systems. All components should be final tightened per the specifications in the Surgical Technique. Implants should not be tightened past the locking point, as damage to the implant may occur. Caution: Add 10mm to the measured length whenever a single ball rod is used. Single Use: Reuse of a single use device that has come in contact with blood, bone, tissue or other body fluids may lead to patient or user injury. Possible risks associated with reuse of a single use device include, but are not limited to, mechanical failure, material degradation, potential leachables, and transmission of infectious agents. Resterilization may result in damage or decreased performance. Patient Education: Preoperative instructions to the patient are essential. The patient should be made aware of the limitations of the implant and potential risks of the surgery. The patient should be instructed to limit postoperative activity, as this will reduce the risk of bent, broken or loose implant components. The patient must be made aware that implant components may bend, break or loosen even though restrictions in activity are followed. Magnetic Resonance (MR) Safety: The SpheRx Spinal System has not been evaluated for safety and compatibility in the MR environment. The SpheRx Spinal System has not been tested for heating or migration in the MR environment. Compatibility: Do not use SpheRx with components of other systems. Unless stated otherwise, NuVasive devices are not to be combined with the components of another system. 24

27 INSTRUCTIONS FOR USE PREOPERATIVE WARNINGS 1. Only patients that meet the criteria described in the indications should be selected. 2. Patient condition and/or predispositions such as those addressed in the aforementioned contraindications should be avoided. 3. Care should be used in the handling and storage of the implants. The implants should not be scratched or damaged. Implants and instruments should be protected during storage, and from corrosive environments. 4. All non-sterile parts should be cleaned and sterilized before use. 5. Devices should be inspected for damage prior to implantation. 6. Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient. POST-OPERATIVE WARNINGS During the postoperative phase it is of particular importance that the physician keeps the patient well informed of all procedures and treatments. Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration as well as to other complications. To ensure the earliest possible detection of such catalysts of device dysfunction, the devices must be checked periodically postoperatively, using appropriate radiographic techniques. 25

28 EC REP To order, please contact your NuVasive Sales Consultant or Customer Service Representative today at: NuVasive, Inc Lusk Blvd., San Diego, CA USA phone: fax: NuVasive UK Ltd. Suite B, Ground Floor, Caspian House, The Waterfront, Elstree, Herts WD6 3BS UK phone: +44 (0) fax: +44 (0) NuVasive, Inc. All rights reserved., NuVasive, Speed of Innovation, MAS, MaXcess, NVM5, SpheRx, and XLIF are registered trademarks of NuVasive, Inc C 0086