Surgical Technique e Guide
SECURIS Pedicle Screw System for Minimally Invasive Surgery Securis Pedicle Screw System has been engineered to provide temporary posterior stabilization of the thoracolumbar spine during the development of fusion in patients. The cannulated pedicle screws are designed to be used in minimally invasive or open approaches. The system is intended for posterior intervertebral screw fi xation of the thoracolumbar spine at levels T1 S1. Securis Pedicle Screw System is comprised of cannulated pedicle screws in various diameters and lengths as well as rods in various lengths and blockers that are assembled to create a temporary construct providing stabilization and promoting thoracolumbar spinal fusion. Special thanks to Ashok Biyani, M.D., Timothy Kuklo, M.D., and Faheem Sandhu, M.D. for their assistance with the development of this product. 2 I SECURIS Pedicle Screw System
IMPLANTS The Securis Pedicle Screw system includes self-tapping, cannulated pedicle screws which are made of titanium. The rods are 5.0mm in diameter and made from Cobalt Chrome. The material properties of Cobalt Chrome [CO-28CR-6MO, ASTM F1537] allow a 5.0mm Cobalt Chrome rod to have greater bending stiffness than a rod of the same diameter made from titanium alloy [Ti-6Al-4V, ASTM F136]. Based upon beam theory calculations, a 5.0mm Cobalt Chrome rod has approximately the same bending stiffness as a 5.85mm titanium rod. The ability to use a smaller rod allows the profi le of the screw head to sit lower than systems using larger titanium rods. Titanium and Cobalt Chrome have a long history of biocompatibility in orthopaedic implants. DIMENSIONS SCREWS RODS Catalog # Description Catalog # Description 115530 5.5mm x 30mm pedicle screw 115535 5.5mm x 35mm pedicle screw 115540 5.5mm x 40mm pedicle screw 115545 5.5mm x 45mm pedicle screw 115550 5.5mm x 50mm pedicle screw 116535 6.5mm x 35mm pedicle screw 116540 6.5mm x 40mm pedicle screw 116545 6.5mm x 45mm pedicle screw 116550 6.5mm x 50mm pedicle screw 116555 6.5mm x 55mm pedicle screw 117535 7.5mm x 35mm pedicle screw 117540 7.5mm x 40mm pedicle screw 117545 7.5mm x 45mm pedicle screw 117550 7.5mm x 50mm pedicle screw 117555 7.5mm x 55mm pedicle screw 115035 35mm Curved Rod 115040 40mm Curved Rod 115045 45mm Curved Rod 115050 50mm Curved Rod 115055 55mm Curved Rod 115060 60mm Curved Rod 115065 65mm Curved Rod 115070 70mm Curved Rod 115080 80mm Straight Rod 115120 120mm Straight Rod 115160 160mm Straight Rod 115240 240mm Straight Rod *80, 90, and 100mm curved rods available upon request Diameters 5.5mm 6.5mm 7.5mm BLOCKER 113000 Blocker 5.0mm Diameter Cobalt Chrome Rods Blocker with 0 threads CUSTOM SPINE, INC. I 3
PEDICLE TARGETING Patient is placed in the prone position on a radiolucent table. Using fluoroscopy, capture an A/P image of the targeted vertebral body. To locate the pedicle s lateral border, place a Guidewire [119001] in the cephalad/caudal orientation and under fluoroscopic image guidance to determine the desired vertical location. Mark the vertical location using a sterile pen. Once the pedicle s lateral border is identified, rotate the Guidewire perpendicular to the vertical line and identify desired placement under image guidance. Mark horizontal placement on the skin with a sterile pen. The intersection of the vertical and horizontal lines marks the pedicle locations. ACCESSING THE PEDICLE Securis, pedicle screw system, is designed to be used in either a minimally invasive approach, using a retractor or portal access system, or as an open approach. Once the pedicle locations have been identified, carefully determine the appropriate entry point(s) and trajectory for the pedicle access system selected. 4 I SECURIS Pedicle Screw System
NEEDLE POSITIONING Insert the Bone Access Needle [119000] into a previously identified pedicle location. Confirm appropriate placement using both A/P and lateral images. Once correct needle position is confirmed, advance the Bone Access Needle into the pedicle. Note: Continuously monitor the position of the bone access needle during insertion. GUIDEWIRE Wire Holder [119007] Remove the inner trocar of the Bone Access Needle, leaving the outer sleeve attached to the t-handle. Insert the Guidewire [119001] through the Bone Access Needle, using the cannulated access of the t-handle. Confirm placement of the Guidewire using fluoroscopy. Once the Guidewire position has been confirmed, maintain location using the Wire Holder [119007] and further advance the Guidewire using a mallet. Once the Guidewire is in place, remove the Bone Access Needle. If performing the procedure using a percutaneous access system, dilate the muscle for access to the pedicle. Note: Guidewire is 1.3mm in diameter and is a single use instrument. Tip: Care must be taken to ensure that the Guidewire remains securely in position throughout the entire duration of the procedure. Important: Continuously monitor the depth of the Guidewire to ensure it does not inadvertently advance, penetrating the anterior wall of the vertebral body. CUSTOM SPINE, INC. I 5
PEDICLE PREPARATION Attach the cannulated Rasp [119002] to the ratcheting T- handle [119008] and place the instrument over the Guidewire. Slide the Rasp down the Guidewire to the pedicle. Make a small incision as needed around the Guidewire to allow the Rasp to access the pedicle. Using a clockwise motion, turn the Rasp 2-3 turns to create a recess for the shoulder of the Securis bone screw. This recess will allow the bone screw to fully seat in the pedicle. Once the recess is complete, remove the Rasp. Securis pedicle screws are cannulated, self-tapping screws. It is recommended to tap hard bone. Select the appropriate diameter Tap and attach to T-handle. Taps are available in 5.5, 6.5 and 7.5mm sizes which correspond to the screw diameters. Slide the cannulated Tap over the Guidewire to the pedicle to prepare the bone for screw insertion. Advance the Tap into the pedicle turning clockwise using image guidance to ensure that the tap does not penetrate further than the Guidewire s distal tip. Note: While advancing the tap, continuously monitor the depth of the Guidewire and hold it to prevent unintentional advancement. Rasp [119002] Taps 119003 5.5mm Tap 119004 6.5mm Tap 119005 7.5mm Tap 6 I SECURIS Pedicle Screw System
SCREW INSERTION Attach the Screwdriver [119011] to the T-Handle [119008]. Select the desired screw diameter and length. Attach selected screw to the Screwdriver assembly by inserting the sides of the screw head into the cut-outs of the Screwdriver shaft. Push the screw head into the shaft of the driver to allow the tangs on the shaft of the driver to slide into two groves on opposite sides of the bone screw. Turn the knob clockwise to lock the screw to the driver providing a toggle-free screw/driver interface. Important: Continuously monitor the Guidewire to ensure it is not being advanced while inserting the screw to avoid penetration of the anterior wall of the vertebral body. Slide the screw and driver over the Guidewire, which will run through the shaft of the driver and out of the center of the T-handle. Advance the screw using a clockwise rotation on the ratcheting T-handle. Remove the Guidewire after the screw has been advanced 2 3 revolutions. The screw should be fully inserted into the pedicle with the shoulder of the bone screw sitting in the recess created previously with the Rasp. Given the design of the Securis pedicle screw, full polyaxial motion is maintained with a fully seated bone screw. Using fl uoroscopy, confi rm the position of the bone screw. To disengage the bone screw, turn the knob in a counter clockwise motion. To disengage the bone screw, turn the knob in a counter clockwise motion until the spring-loaded knob pops-up vertically, a signal that the driver is fully released from the screw. Screwdriver [119011] T-Handle [119008] CUSTOM SPINE, INC. I 7
SCREW HEAD POSITIONING For successful rod insertion, the screw heads must be in alignment. Attach the T-handle to the Screw Adjuster [119012]. Manipulate the screw heads as needed to ensure proper alignment. Screw Adjuster [119012] ROD SELECTION Once all pedicle screws are inserted, select the desired rod length. The Cobalt-Chrome rods are 5.0mm in diameter with a choice of pre-bent rods in 35 70mm lengths and straight rods in 80 240mm lengths. Rod Bender [119016] When rod contouring is desired, use the Rod Bender [119016] to contour the selected rod as needed by inserting the rod into the head of the bender and compressing the handles. Tip: Do not bend the rod in reverse after initial contour in order to optimize the mechanical integrity of the rod. 8 I SECURIS Pedicle Screw System
ROD INSERTION Use the Rod Inserter [119017] to place the rod in the previously aligned screw heads for retractor and open access procedures. For percutaneous procedures, follow the instructions for rod insertion provided with the system. Rod Inserter [119017] Grip the middle of the rod with the pivoting Rod Inserter. Once the rod is secure, pivot the tip so that the rod is somewhat parallel to the Rod Inserter. Place the end of the rod into the caudal screw head and apply pressure to the rod, which will allow the rod to articulate from the vertical to horizontal position. Place the rod in the screw heads, then disengage the instrument to release the rod. Note: It is recommended that approximately 4mm of the rod extend beyond the head of the screw on both the superior and inferior ends of the construct. In addition, the pivoting grip of the Rod Inserter requires regular oiling to maintain smooth articulation. BLOCKER INSERTION The Blocker Inserter [119015] is double-ended allowing a blocker to be attached at both ends. Attach the blocker to the Blocker Inserter by simply pressing down on the blocker and insert into the screw head. Insert the blocker into the screw head by turning clockwise until fi nger tight. At this point the blocker is ready for fi nal-tightening. Note: Inspect each screw head to ensure the rod is fully seated before attempting to insert the blocker. If the rod sits proud in any of the screw heads, follow the rod reduction instructions to fully seat the rod. Once the rod is fully seated in the screw head, insert the blocker through the Rod Reducer to the screw head and tighten. Blocker Inserter [119015] 15] CUSTOM SPINE, INC. I 9
ROD REDUCTION In some cases, it may be necessary to reduce the rod into the screw head. The Rod Reducer [119019] is designed to achieve up to 10mm in reduction. Align the sides of the Rod Reducer shaft with the sides of the screw head allowing the rod to fi t in the aligned cut-outs of the screw head and reducer shaft. Ensure the tangs of the Rod Reducer shaft fi t into the grooves of the bone screw. Once in alignment, squeeze the ratcheting scissor handle to fully seat the rod. Insert the blocker inserter with blocker attached through the shaft of the Rod Reducer and insert the blocker to fi nger tight. Rod Reducer [119019] 10 I SECURIS Pedicle Screw System
SCREW ADJUSTMENT In some cases, the bone screw may need to be adjusted to fully seat the rod. Use the Screw Adjuster [119012] to make fi ne adjustments to the bone screw. Attach the Screw Adjuster to the T-handle. Position the Screw Adjuster in the screw head so that the sides of the screw insert over the cut-out in the shaft of the Screw Adjuster. Position the tangs on the end of the Screw Adjuster into the grooves of the bone screw. Rotate to achieve desired height and position. Screw Adjuster [119012] CUSTOM SPINE, INC. I 11
DISTRACTION The Securis pedicle screw system offers three distraction options. Option1: Rack Distractor [119014] Once the screws have been placed, rotate the screw heads so that the rod cut-out is positioned medial-lateral. Insert the spherical legs of the Rack Distractor into the desired screw heads using the Rod Inserter. Pivot the distractor medially by pushing on the ratcheting slide bar to provide a lateral working window. Insert the blockers and lightly fi nger tighten to temporarily secure the Rack Distractor. Use the Standard Distractor [119013] to ratchet open the distractor legs to the desired position. For removal, release the tension by applying slight distraction force between screw heads, then disengage the blockers and remove the Rack Distractor. Option 2: Standard Distractor [119013] At this time, the vertebral motion segment has a bone screw inserted on adjacent levels of the disc space. Tighten the blocker on one of these bone screws and do not tighten the adjacent level blocker where distraction is desired. Place the Standard Distractor on the rod between the screw heads. Distraction is achieved by squeezing the ratcheting distraction handles. Tighten the adjacent blocker while maintaining distraction. Option 3: Compressor/Distractor [119020] For distraction, place the angled end of the Compressor/Distractor [119020] on the rod and against the screw head. Ensure that the screw you are distracting against has been fi nal tightened and that a blocker has been inserted and fi nger tightened on the screw from which you are distracting. Place the Counter Torque Wrench [119021] on the head if the screw you are distracting which has the fi nger tightened blocker. The Compressor/Distractor should be positioned against the screw head which has been fi nal tightened. 12 I SECURIS Pedicle Screw System Lever the Compressor/Distractor towards the counter Torque Wrench until the desired distraction is achieved. Insert the Torque Wrench into the Counter Torque Wrench and fi nal tighten.
COMPRESSION When performing compression, ensure that the screw you are compressing against has been fi nal tightened and that a blocker has been inserted and fi nger tightened on the screw to which you are compressing. Insert the fl at sides of the distal end of the Counter Torque Wrench [119021] through the cut-out in the Compressor /Distractor [119020] and rotate the Counter Torque Wrench 90 degrees. Apply the Counter Torque Wrench on the head of the screw which has the fi nger tightened blocker. The compressor should be attached to the screw head which has been fi nal tightened. Lever the Compressor/Distractor towards the Counter Torque Wrench until the desired compression is achieved. Insert the Torque Wrench into the counter Torque Wrench and fi nal tighten. Note: Not using the counter torque wrench during fi nal tightening may damage the screw and/or blocker or may lead to construct loosening. Compressor/Distractor [119020] Counter Torque Wrench [119021] CUSTOM SPINE, INC. I 13
FINAL TIGHTENING The torque limiting handle has a prescribed 9.5Nm of torque. Once this limit is achieved, the torque handle skips ensuring the appropriate amount of torque is applied without a breakaway once achieved. Place the Counter Torque Wrench [119021] over the screw head. Once secure to the screw, insert the Final Tightener [119018] with Ratcheting Torque Handle [119009] attached, into the Counter Torque Wrench and affi x into the blocker. Turn the torque limiting handle clockwise until the resistance releases and you can feel the handle skipping. Note: Not using the counter torque wrench during fi nal tightening may damage the screw and/or blocker or lead to construct loosening. Final Tightener [119018] Ratcheting Torque Handle [119009] 14 I SECURIS Pedicle Screw System
REVISION/REMOVAL For removal of the construct, attach the ratcheting T-handle [119008] to the Final Tightener [119018]. Place the Counter Torque Wrench on the screw, and place the fi nal tightener through the Counter Torque Wrench into the screw head. Rotate the T-handle on the Final Tightener counterclockwise to loosen and remove blockers with the self-retaining Blocker Inserter. Once the blockers have been removed, used the Rod Inserter [119017] to remove the rods. To remove the screws, insert the tip of the Revision Tool [119022] with T-handle attached into the screw head. Rotate the T-handle clockwise until moderately tight. Release the T-handle. To remove the screw, rotate the Revision Tool counter clockwise using the integrated handle. Revision Tool [119022] CUSTOM SPINE, INC. I 15
IMPLANTS AND INSTRUMENTS SET Securis Pedicle Screw System Tray 1 [119100] IMPLANTS LOWER LEVEL Product Number Description Quantity 115530 5.5mm x 30mm cannulated screw 4 115535 5.5mm x 35mm cannulated screw 6 115540 5.5mm x 40mm cannulated screw 6 115545 5.5mm x 45mm cannulated screw 6 115550 5.5mm x 50mm cannulated screw 4 116535 6.5mm x 35mm cannulated screw 4 116540 6.5mm x 40mm cannulated screw 8 116545 6.5mm x 45mm cannulated screw 8 116550 6.5mm x 50mm cannulated screw 8 116555 6.5mm x 55mm cannulated screw 4 117535 7.5mm x 35mm cannulated screw 4 117540 7.5mm x 40mm cannulated screw 6 117545 7.5mm x 45mm cannulated screw 6 117550 7.5mm x 50mm cannulated screw 4 117555 7.5mm x 55mm cannulated screw 2 115035 35mm curved rod 4 115040 40mm curved rod 4 115045 45mm curved rod 4 115050 50mm curved rod 4 115055 55mm curved rod 4 115060 60mm curved rod 4 115065 65mm curved rod 4 115070 70mm curved rod 4 115080 80mm straight rod 4 115120 120mm straight rod 4 115160 160mm straight rod 2 115240 240mm straight rod 2 113000 Blocker 20 *80, 90 and 100mm curved rods available upon request 16 I SECURIS Pedicle Screw System
IMPLANTS AND INSTRUMENTS SET Securis Pedicle Screw System Tray 1 [119100] INSTRUMENTS UPPER LEVEL Product Number Description Quantity 119001 Guidewire 12 119002 Rasp 1 119003 Tap 5.5mm 1 119004 Tap 6.5mm 1 119005 Tap 7.5mm 1 119007 Wire Holder 1 119008 Ratcheting T-Handle 2 119009 Ratcheting Torque Handle 1 119015 Blocker Inserter 2 119018 Final Tightener 2 CUSTOM SPINE, INC. I 17
IMPLANTS AND INSTRUMENTS SET Securis Pedicle Screw System Tray 2 [119100] INSTRUMENTS UPPER LEVEL Product Number Description Quantity 119011 Screwdriver 2 119012 Screw Adjuster 1 119013 Distractor 1 119014 Rack Distractor 1 119016 Rod Bender 1 119017 Rod Inserter 1 INSTRUMENTS LOWER LEVEL Product Number Description Quantity 119019 Rod Reducer 1 119020 Compressor 1 119021 Counter Torque Wrench 1 119022 Revision Tool 1 18 I SECURIS Pedicle Screw System
CUSTOM SPINE CUSTOM SPINE Securis Pedicle Screw System CAUTION: Federal law (U.S.A.) restricts this device to sale by or on the order of a licensed physician. NON STERILE PRODUCT MUST BE STERILIZAED PRIOR TO USE SINGLE USE ONLY THE SECURIS PEDICLE SCREW SYSTEM HAS NOT BEEN EVALUATED FOR SAFETY AND COMPATABILITY IN THE MR ENVIRONMENT. THE SECURIS SPINAL FIXATION SYSTEM HAS NOT BEEN TESTED FOR HEATING OR MIGRATION IN THE MR ENVIRONMENT. SECURIS PECICLE SCREW CONNECTORS ARE USED FOR PEDICULAR FIXATION IN THE IMMOBILIZATION AND STABILIZATION OF THE POSTERIOR NON CERVICAL (T1-S1) SPINE. NON STERILE PRODUCT The Custom Spine Securis Pedicle Screw System is comprised of spinal implants for fixation of the non-cervical spine. This includes: rods, screws and blockers. The components are manufactured from titanium alloy and chromium-cobalt. The screws are available in various sizes from 5.5mm to 7.5mm diameters with lengths ranging from 30mm to 55mm. MATERIALS Titanium alloy: Ti6-Al-4V according to ISO 5832-3, ASTM F-136 and Chromium-Cobalt, ASTM F-1537: (NOTE: Titanium and stainless steel implants should not be mixed in patients as corrosion may occur resulting in decreased mechanical performance) INDICATIONS The FDA regulation restricts the use of pedicle screw fixation as follows: The SECURIS Spinal Fixation System is intended for the immobilization and stabilization of the thoraco-lumbar-sacral spine (T1-S1) as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis,fracture,dislocation,scoliosis,kyphosis,spinal tumor, and previously failed fusion (pseudoarthrosis). CONTRAINDICATIONS Contraindications may be relative or absolute. The choice of a particular device must be carefully weighed against the patient s overall evaluation. Circumstances listed below may reduce the chances of a successful outcome: Any abnormality present which affects the normal process of bone remodeling including, but not limited to, severe osteoporosis involving the spine, active infection at the site or certain metabolic disorders affecting osteogenesis. Insufficient quality or quantity of bone which would inhibit rigid device fixation. Previous history of infection. Excessive local inflammation. Open wounds. Any neuromuscular deficit which places an unusually heavy load on the device during the healing period. Obesity. An overweight or obese patient can produce loads on the spinal system which can lead to failure of the fixation of the device or to failure of the device itself. Patients having inadequate tissue coverage of the operative site. Pregnancy. A condition of senility, mental illness, or substance abuse. These conditions, among others, may cause the patient to ignore certain necessary limitations and precautions in the use of the implant, leading to failure or other complications. Foreign body sensitivity. Where material sensi tivity is suspected, appropriate tests should be made prior to material selection or implantation. Other medical or surgical conditions which would preclude the potential benefit of spinal implant surgery, such as the presence of tumors, congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white blood cell count (WBC), or marked left shift in the WBC differential count. These contraindications can be relative or absolute and must be taken into account by the physician when making his decision. The above list is not exhaustive. CAUTION: Federal law (U.S.A.) restricts this device to sale by or on the order of a licensed physician. Pedicle Screw implantation should only be performed by experienced spinal surgeons with specific training in the use of the Securis Spinal Fixation System. This is a technically demanding procedure with a risk of serious patient injury. 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 spondylolisthesis (grades 3 and 4) of the L5-S1vertebrae, degenerative spondylolisthesis with objective evidence of neurological impairment, fracture dislocation, scoliosis, kyphosis, spinal tumor, and failed pervious fusion. (Pseudoarthrosis) The safety and effectiveness of these devices for any other conditions are unknown. CUSTOM SPINE, INC. I 19
Custom Spine, Inc. 9 Campus Drive Parsippany, NJ 07054 Phone (973) 808-0019 Fax (877) 770-7746 www.customspine.com Product Number 001070. Rev. B