Biomet Omega21 TM Spinal Fixation System

Transcription

1 Biomet Omega21 TM Spinal Fixation System Surgical Technique Coronal Angulation 50% Axial Angulation Infinite Sagittal Angulation

2 Contents Introduction... Page 1 System Design Features And Benefits... Page 2 Implants... Page 3 Instrumentation... Page 5 Surgical Technique... Page 9 Additional Surgical Options... Page 18 Closure, Implant Removal... Page 24 Ordering Information... Page 25 Indications / Contraindications... Page 28 Sterilization Recommendations... Page 29 Further Information... Page 30

3 Introduction The advanced design of the Biomet Omega21 TM Spinal Fixation System allows for convenient, quick and efficient procedures. Minimal implants and instrumentation space facilitate a more efficient procedure. The system employs self-tapping bone screws eliminating the need for preliminary tapping and allowing for easy insertion fixation in the pedicle. For challenging cases in which compromised bone is an issue, the system offers Expandable Screws (not self-tapping)which expand up to 2mm at the distal tip to ensure maximum bone purchase. The unique multidirectional coupler design accommodates multi-planar bone screw angulation and minimizes the amount of rod contouring required. The system also features one-step top loading/top tightening, providing efficiency during locking. For convenience, the rods are available in pre-cut 5mm increments. The manufacturing process incorporates a roughened finish on the rod and coupler providing an enhanced frictional lock. All implant components are constructed of titanium alloy providing excellent biomechanical performance and imaging capabilities. Coronal Angulation 50% Axial Angulation Infinite Sagittal Angulation 1

4 System Design Features And Benefits Features Self-tapping screws Benefits No need for preliminary tapping Easy insertion Versatile Rod to Screw Connection Multidirectional coupler Accommodates screw angulation in three planes: axial, sagittal and coronal Slotted multidirectional coupler Accommodates screw angulation in three planes: axial, sagittal and coronal Accommodates for medial-lateral adjustments Advanced Locking Mechanism Efficient one-step design secures the rod to the screw Top loading / top tightening Spherical grommet style coupler ensures a true 360 circumferential frictional lock around the rod Manufacturing process incorporates a roughened finish on the coupler providing an enhanced frictional lock around the rod Innovative Rod Design Pre-cut in convenient 5mm increments Eliminates the need for cutting Utilizing the appropriate length rod may aid in facet preservation Manufacturing process-incorporates a roughened finish providing an enhanced frictional lock Hex tipped end allows for efficient intraoperative rod manipulation 2

5 Implants Lock Nut Top View Bottom View Self-Tapping Screws Spondylolisthesis Self-Tapping Screws Available in 5.5mm, 6.35mm and 7.5mm diameters Ranging in length from (30mm - 60mm) in 5mm increments Rods Expandable Screws Roughened finish provides an enhanced frictional lock 6mm diameter in pre-cut lengths - 35mm - 75mm (in 5mm increments) - 75mm - 205mm (in 5mm increments) - 225mm - and 255mm Avaialable in 7.0mm and 8.0mm diameters Ranging in length from (30mm - 50mm) in 5mm increments Expandable Screws are NOT self tapping Transverse Rods Couplers Multidirectional Design accommodates screw angulation in three planes: - Sagittal Coronal Axial - Unlimited 4mm diameter Available in pre-cut lengths - 40mm - 60mm - 80mm Transverse Rod Connector Slotted Multidirectional Coupler Design accommodates for medial-lateral adjustments mm 18.5mm Connector attaches to the longitudinal rod and the transverse rod Two are required for transverse connection 3

6 Implants (Continued) Hooks Laminar Wide and narrow blades Standard and reduced throat configurations 6mm, 8mm, 10mm throat depths Pedicle 6mm, 8mm, 10mm throat depths Angled 8mm throat depth Left and right 4

7 Instrumentation Pedicle Awl 9mm Cannulated Wrench Screw Retainer Pedicle Probe Straight Pedicle Probe Angled Pedicle Reamer Probe Ratcheting Screw Inserter - Handle And Shaft Coupler Guide Reamer Probe Driver Pedicle Sound Rod Holder 5

8 Instrumentation (Continued) French Rod Bender Soft Tissue Retractor Compression Forceps Transverse Rod Holder Distraction Forceps Transverse Connector Forceps Counter Rotation Hex Wrench 6mm Locknut Driver 6

9 2.5mm Hex Wrench 9mm Torque Wrench Closed Rod Positioner Simple Cannulated Stabilizer Open Rod Positioner Slotted Cannulated Stabilizer 6mm Torque Wrench In-Situ Rod Benders 7

10 Instrumentation (Continued) Hook Starters Hook Forceps Angled Hook Inserter Separate Hook Impactor Threaded Hook Inserter 8

11 Surgical Technique Surgical Approach And Preparation After positioning the patient in the customary manner, the spine is exposed via a midline or paraspinal incision. Paraspinal musculature is retracted laterally, and a discectomy or posterior decompression is performed if indicated. Decortication must be meticulously performed. Graft can be placed or packed into the posterolateral gutters either before or after the Biomet Omega21 System has been implanted. Pedicle Preparation The entrance to the pedicle is marked with the pedicle Select the appropriate pedicle reamer probe After adequate exposure, the appropriate pedicle entry point is selected and the pedicle is prepared. The entrance to the pedicle is marked with an awl, burr, or curette. The cancellous bone within the cortical tube of the pedicle is sounded using a probe. A Steinmann pin can be placed into the pedicle, and its positioning confirmed on AP and lateral radiographs, if desired by the surgeon. The Pedicle Reamer Probe can also be utilized eliminating the need for a guide pin. It may be left in place to assure proper orientation and trajectory on radiograph. Pedicle Reamers are available with each set and can be inserted prior to obtaining radiographs. Attach the pedicle reamer to the reamer drive The entrance to the pedicle is selected Advance the pedicle reamer to a depth of approximately 30mm 9

12 Surgical Technique (Continued) Pedicle Preparation (Continued) The Pedicle Reamer creates a hole the same size as the minor diameter of the screw. The Pedicle Reamer has the corresponding screw diameter etched on the shaft; e.g. 6.35mm Pedicle Reamer is used for the 6.35mm diameter screw. The appropriate diameter reamer is attached to the Reamer Probe Driver and used to prepare the pedicle using a slow circular motion, allowing the reamer to center itself along the longitudinal axis of the pedicle. Instead of the Pedicle Reamer, a ball handle pedicle probe (straight or curved style) can also be used. The pedicle probe is inserted gently with a small rotary motion. The depth markings on the probe confirm appropriate screw length. After removal of the reamer or probe, pedicle wall integrity can be palpated using a flexible sound probe to confirm containment. Other confirmatory tests can also be used. Utilizing the ball handle pedicle probe As stated previously, multiple Pedicle Reamers can be inserted and proper positioning confirmed by C-arm. The reamer is initially advanced to a depth of approximately 30mm using the depth guide on the reamer. If Expandable Screws are to be utilized, one must tap the pedicle prior to screw insertion. Confirm proper pedicle positioning radiographically A flexible sound probe is utilized to confirm containment 10

13 Screw Selection and Insertion Self-tapping Screws are available in several diameters and lengths. The appropriate screw length is determined by using the depth gauge on the Pedicle Reamer Probe or ball handle pedicle probe. The Screw Retainer is inserted through the center of the 9mm Cannulated Wrench. The screw is placed into the 9mm Cannulated Wrench and the Screw Retainer is threaded clockwise onto the outer threads of the screw until the screw is firmly seated within the wrench. (For the Spondy Screw, the Spondy Screw Tool is utilized instead of the Screw Retainer. The Spondy Screw Tool is cannulated and shorter than the Screw Retainer.) The screw is advanced into the pedicle until the outer edge of the wrench firmly seats against bone. The wrench is disengaged from the screw by unscrewing the Screw Retainer and removing both instruments together. All standard Self-tapping Screws and Expandable Screws are inserted in the same manner as described above (prior to insertion of the Expandable Screw, one must tap the pedicle). The Screw Retainer is inserted through the 9mm Cannulated Wrench The screw is attached to the wrench The screw is advanced into the pedicle The wrench is disengaged 11

14 Surgical Technique (Continued) Screw Selection And Insertion (Continued) As an alternative to utilizing the 9mm Cannulated Wrench and the Screw Retainer to insert the screws, the Ratcheting Screw Inserter may be used instead. Retract the plunger on the Ratcheting Screw Inserter Handle. Insert the Ratcheting Screw Inserter Shaft into the Handle and release the plunger to lock the shaft in place. Ensure that the ring on the handle is in the forward position. Firmly press the screw into the distal tip of the shaft to engage the capture ring. Advance the screw into the pedicle in a clockwise position. Disengage the instrument from the screw by gently pulling back on the handle. All Standard Self-tapping Screws are inserted in the same manner. Ensure the handle is in the forward position Press the screw into the distal tip of the shaft Prior to inserting the Expandable Screw, the expansion peg must engage the first thread of the screw. This is achieved by turning the expansion peg one complete turn. Please note that the screw should not be expanded before insertion. Tap the pedicle prior to insertion of the Expandable Screw, then insert the Expandable Screw in the same manner as described above with the Standard Self-tapping Screws. After insertion, use the 2.5mm Hex Wrench to advance the expansion peg. This will expand the distal tip of the screw up to 2mm. Advance screw in a clockwise direction Insert the shaft of the Ratcheting Screw Inserter into the handle Gently pull back on the handle to disengage the instrument 12

15 Rod Application Once all screws have been inserted, the appropriate length rod should be chosen according to the construct. Rods are available pre-cut in 5mm increments. Utilize the Malleable Trial Rod to measure the distance between screw heads to determine the rod length needed. Be sure to account for large curves and distractions when choosing rod length. The selected rod is properly bent to fit the desired spinal contours utilizing the Rod Bender. When using the Rod Bender, confirm that it is positioned on the appropriate number (6.35) prior to contouring. Minimal contouring is required due to the multidirectional coupler. Assemble couplers on the rod Select the appropriate coupler Next, the proper couplers are chosen. One coupler is required for each screw. Couplers are available in a multidirectional or slotted multidirectional style. The appropriate number of couplers is assembled on the rod. Place the male hex tip of the Coupler Guides into the female hex on the screw heads. Once the guides are positioned, the Rod Holder is used to situate the rod and coupler assembly into place on the screw heads. The rod may be placed either medially or laterally. The open arm of the coupler is placed over the machine thread portion of the screw. Pre-loaded rod with couplers Utilize the Rod Bender to contour the rod The rod and coupler assembly is placed utilizing the Rod Holder 13

16 Surgical Technique (Continued) Lock Nut Application When all screws have been inserted and the corresponding couplers applied, the construct is then secured using lock nuts. Lock nuts should be applied in sequential order utilizing the 9mm Cannulated Wrench in combination with the Counter Rotation Hex Wrench. The Counter Rotation Hex Wrench is inserted through the center of the 9mm Cannulated Wrench. Lock nuts are loaded onto the threads located on the distal portion of the Counter Rotation Hex Wrench. Secure the distal end of the Soft Tissue Retractor under the shoulder of the screw to form a protective wall between the Cannulated Wrench and the soft tissue. The Cannulated Wrench will fit within the hemispherical shaft of the retractor. Load lock nut on Counter Rotation Hex Wrench The lock nut is ready for insertion Lock Nut The Counter Rotation Hex Wrench is inserted through the 9mm Cannulated Wrench The 9mm Cannulated Wrench fits within the shaft of the Soft Tissue Retractor The 9mm Cannulated Wrench is turned clockwise and the lock nut is provisionally tightened 14

17 The distal male tip of the Counter Rotation Hex Wrench is fully seated into the female hex of the screw and positioned in the same trajectory as the top of the screw to ensure proper lock nut thread engagement. The 9mm Cannulated Wrench is turned clockwise and the lock nut is advanced onto the machine threaded portion of each screw as it protrudes through the coupler arm. The Counter Rotation Hex Wrench stabilizes the Screw and should not be turned during lock nut advancement. Lock nuts should be placed in sequential order and provisionally tightened using the Cannulated Wrench in combination with the Counter Rotation Hex Wrench. The Rod Holder may be utilized to help stabilize the rod during provisional tightening. The lock nut is provisionally tightened at this point. Repeat these steps until all lock nuts have been applied. Rod Manipulation Prior to final lock nut tightening, rod manipulation may be accomplished by utilizing the Open or Closed Rod Positioner. The Rod Positioner is placed around the hex tip of the pre-cut rod and the desired manipulation is performed. The Counter Rotation Hex Wrench tip is placed into the female hex of the screw Rod manipulation utilizing the Rod Positioner 15

18 Surgical Technique (Continued) Final Locking With The Torque Wrench After provisional tightening, proper implant and spinal positioning should be confirmed. The lock nuts can then be firmly tightened with the self-limited 9mm Torque Wrench in combination with the Counter Rotation Hex Wrench. Utilize the Simple Cannulated Stabilizer at those levels using a Standard Multidirectional Coupler. Insert the Counter Rotation Hex Wrench through the center of the Torque Wrench and then insert the assembly through the Stabilizer. Position the male tip of the Counter Rotation Hex Wrench into the corresponding female hex of the screw. The Torque Wrench is engaged around the lock nut. Place the Stabilizer so that the neck of the coupler engages within the distal slots of the Stabilizer. At those levels utilizing a Slotted Multidirectional Coupler, use the Slotted Cannulated Stabilizer. Repeat the procedure described above with the Simple Cannulated Stabilizer but position the Slotted Cannulated Stabilizer so that the Slotted Multidirectional Coupler engages within the pegs at the distal tip of the Stabilizer. During torquing, the Construct Stabilizer is turned in the opposite direction to provide counter rotation. Again, the Counter Rotation Hex Wrench should not be turned during locknut application. If contouring is desired after final torquing, apply the In Situ Benders to the rod at the appropriate caudal and cephalad positions and bring the handles together to apply correction as needed. Insert the Counter Rotation Hex Wrench through the Torque Wrench Insert the Torque Wrench assembly through the Cannulated Stabilizer 16

19 Standard Multidirectional Coupler Utilize the Simple Cannulated Stabilizer when using a Standard Multidirectional Coupler. Insert the Counter Rotation Hex Wrench through the center of the Torque Wrench and then insert the assembly through the Cannulated Stabilizer. Position the male tip of the Counter Rotation Hex Wrench into the corresponding female hex of the screw. The Torque Wrench is engaged around the lock nut. Place the Stabilizer so that the neck of the coupler engages within the distal slots of the Stabilizer. With the hex tip of the Counter Rotation Hex Wrench engaged in the screw, the screw is stabilized while the 9mm Torque Wrench is turned in a clockwise manner until the audible click indicates that adequate torque has been applied to secure the lock nut. If the transverse connectors are utilized, the 6mm Torque Wrench must be used to torque the set screw as the last step. The 9mm Torque Wrench provides 90 inch-lbs. and the 6mm Torque wrench provides 60 inch-lbs. The Torque Wrench is turned in a clockwise manner until the audible click is heard Slotted Multidirectional Coupler Utilize the Slotted Cannulated Stabilizer when using a Slotted Multidirectional Coupler. Repeat the procedure described above with the Simple Cannulated Stabilizer but position the Slotted Cannulated Stabilizer so that the Slotted Multidirectional Coupler engages within the pegs at the distal tip of the Stabilizer. During torquing, the Construct Stabilizer is turned in the opposite direction to provide counter rotation. 17

20 Additional Surgical Options Applying Distraction And / Or Compression Transverse Rod Application Distraction and Compression can be achieved by utilizing either the Distraction Forceps or Compression Forceps. Both instruments permit intraoperative application of linear distraction or compression at any level. The distal tips of the distraction or compression forceps are applied to the rod so that the paddles engage the screw heads and the desired degree of distraction or compression is applied. In cases of irregular anatomy, the distal tips of the Compressor are applied to the longitudinal rod to apply curvilinear compression. The distraction or compression device will maintain the position of the vertebra until the lock nut is tightened securing the coupler around the rod. The Rod Holder may be utilized to provide an intermediary point when compressing and/or distracting, if necessary. Applying distraction In the event that additional torsional stability is required, a transverse rod may be utilized. Transverse rods are available in 40mm, 60mm, and 80mm lengths. Two transverse connectors are utilized to secure the rod in the desired location. Place the transverse connector around the 6mm longitudinal rod with the Transverse Connector Forceps and hold it in place. Feed the transverse rod through the connector with the Transverse Rod Holder. Apply a second transverse connector on the opposite side in the same manner. Once the transverse rod is positioned through both connectors, the set screw is provisionally tightened with the 6mm Lock Nut Driver and eventually torqued with the 6mm Torque Wrench. Position the transverse connector in the desired location Insert the transverse rod Applying compression 18

21 Reduction Procedure for Spondylolisthesis Add the second transverse connector For high grade spondylolisthesis, Spondy Screws with the extended machine thread portion may be utilized. The extended machine portion of the screws allows for easier rod introduction in the slipped vertebra and can be used to reduce the spondylolisthesis if desired. The extended machine portion is removed at the end of the procedure to give the screw the same profile as the standard screw. Select the appropriate size spondylolisthesis screw Provisionally tighten the transverse connector with the 6mm lock nut driver Insert the spondylolisthesis screw 19

22 Additional Surgical Options (Continued) Reduction Procedure for Spondylolisthesis (Continued) For L5 spondylolisthesis, reduction may be accomplished by inserting Spondy Screws with the extended machine thread portion in L5 and standard self-tapping screws in L4 and S1. The Spondy Screws are inserted identically to the standard screws except the special Spondy Screw Tool is utilized instead of the Screw Retainer (See Screw Insertion, page 11-12). Once the screws have been inserted, the rod and couplers are applied in the normal manner (See Rod Application, page 13). Lock Nuts are applied on all screws. The L4 and S1 Lock Nuts are fully tightened on both sides. Once the L4 and S1 Lock Nuts are secured, reduction is obtained by simultaneously and gradually tightening the Lock Nuts on the Spondy Screws at the L5 level. Tighten the lock nut beyond the scored mark on the screw After all Lock Nuts have been torqued (See Final Locking with the Torque Wrench, page 16), the extended machine thread portion on the Spondy Screws is removed with the Spondy Screw Tool. The Spondy Screw Tool is applied to the extended machine threads of the screw similar to a lock nut. Once fully engaged, the handle is cantilevered until the excess machine portion breaks at the scored area. Remove the extended machine portion with the Spondy Screw Tool If the broken piece of the machine thread is not disengaging from the Spondy Screw Tool, the 2.5mm Hex Wrench may be inserted through the end of the Spondy Screw Tool and turned in a clockwise direction for removal. The 2.5mm Hex Wrench is utilized to remove the excess machine portion 20

23 Hook Application With supra or infra-laminar hook placement, the interlaminar space is identified after resection of the spinous processes. The ligamentum flavum is divided in the midline with a small curette. A Kerrison Rongeur is used to resect the ligamentum as needed. A small portion of inferior lamina may need to be resected to create space for a supra-laminar hook insertion. A small portion of superior lamina may need to be resected to create space for an infra-laminar hook insertion. The receiving site is prepared with the appropriate Hook Starter. The Threaded Hook Inserter is used to grasp the hook securely and introduce the hook into its correct position. The distal end of the Inserter closes over the threads of the hook in a forcep manner. The hook is then inserted at the previously prepared site and the forceps are opened to release the hook. The hook height needs to be determined based on the laminar thickness. Ideally, a snug fit of the lamina will be achieved between the blade of the hook and the inferior portion of the body of the hook. An anatomic fit will allow the hook to be stationary during rod introduction. Furthermore, this accurate anatomic placement will prevent possible neural impingement. The Hook Impactor can be used to impact the hook into place if needed. The distal end of the Impactor is U-shaped and fits around the distal end of the Threaded Hook Inserter. The proximal end of the Impactor is then tapped to secure the hook at the insertion site. The Hook Impactor is used to impact the hook into place if needed. Laminar site preparation utilizing the Hook Starter. 21

24 Additional Surgical Options (Continued) Hook Application (Continued) With thoracic transverse process hook placement, a right or left angled hook is available for use with the appropriate transverse process. The inter-transverse process ligament is elevated off the superior margin of the transverse process receiving the hook. The appropriate Hook Starter is used to elevate the rib-transverse process ligament from the anterior aspect of the transverse process and create the insertion site. As with Laminar placement, the Threaded Hook Inserter is used to securely grasp the hook for insertion. The Hook Impactor can be used to impact the hook into place if needed. Hook Forceps hold hook in place during lock nut application. With thoracic pedicle hook placement, the spine is exposed in a sub-periosteal plane. The spinous processes are removed with a rongeur. The facet joints are identified bilaterally. A portion of the inferior articular facet is removed with a Capner gouge. This exposes the articular cartilage of the facet that is removed to promote arthrodesis. The Pedicle Hook Starter is passed in a plane adjacent to the superior articular facet. The Pedicle Hook Starter contacts the inferior portion of the pedicle. Once the pedicle margin is identified, a hook can be inserted. As with the Laminar placement the Threaded Hook Inserter is used to hold the hook during its insertion. The Pedicle Hook s bifid blade cradles the inferior aspect of the pedicle, and lies beneath the inferior aspect of the lamina. It is sometimes necessary to resect a portion of the lamina for the hook insertion. The Hook Impactor may be used to seat the hook securely. Lock nut is torqued with Cannulated Stabilizer in position. 22

25 Hook Application (Continued) After the hooks have been inserted, the rod is contoured into the appropriate thoracic kyphosis and/or scoliosis, the couplers are threaded onto the rod, and the assembly is introduced to the hook. During this application, one may choose to use the Hook Forceps to prevent movement of the hook. The distal end of the Hook Forceps grasps the hook along its slotted grooves. The Hook has slots along all four sides to facilitate forcep application regardless of orientation. The lock nuts are applied in the same manner as with the pedicle screws utilizing the 9mm Locknut Driver in conjunction with the Counter Rotation Hex Wrench. The lock nuts are provisionally tightened to allow a derotation of the rod to correct a sagittal or coronal plane deformity. This derotation maneuver can be accomplished utilizing either the Open or Closed Rod Positioner. At this point, one can also utilize the Distractor or Compressor in combination with a Rod Holder, tightened to the rod, to ensure fixation of the hooks with the lamina before final tightening. The final torquing of the lock nuts can be achieved in a similar manner as when using the pedicle screws. The 9mm Torque Wrench in conjunction with the Counter Rotation Hex Wrench is utilized for final torquing of the lock nuts. One should also use the Simple or Slotted Cannulated Stabilizer to provide antitorque, thus stabilizing the construct. After final torquing of the lock nuts, the excess machine threaded portion of the hook is broken off by threading the Spondy Screw Tool over that portion and cantilevering it in a caudal to cephalad direction. Construct after excess machine threaded portions have been removed. Spondy Screw Tool is used to remove excess machine threaded portion after final torquing. 23

26 Closure and PostOperative Care Closure Implant Removal Implant Removal After implantation of the Biomet Omega21 System is complete, closure is performed in layers over drains according to standard protocol. Postoperative Care Removal of the Biomet Omega21 System is performed by reversing the order of the implant procedure. The Torque Wrench, which is multidirectional, must be used first to remove the lock nuts. To enhance recovery following implantation of the Biomet Omega21 System, the patient should be mobilized after a few days. A TLSO brace may be used postoperatively to decrease excessive mobility. Walking-intensive activities should be restricted until otherwise advised by the surgeon. Postoperative radiographs should be taken periodically and reviewed to ensure fixation stability. 24

27 Ordering Information Biomet Omega21 Instrument Case - A #28000 Catalog# Description Qty Rod Bender Open Rod Positioner Rod Holder (Closed) Rod Positioner Transverse Rod Holder Transverse Connector Forceps Spondy Screw Tool Screw Retainer Simple Cannulated Stabilizer Slotted Cannulated Stabilizer Ratcheting Screw Driver Handle Ratcheting Screw Driver Inserter Locknut Driver, 9mm Counter Rotation Hex Wrench Malleable Trial Rod Coupler Guide mm Tap mm Tap Pedicle Awl mm Reamer Probe mm Reamer Probe mm Reamer Probe mm Reamer Probe mm Reamer Probe Pedicle Sound Reamer Probe Driver Pedicle Probe Curved Pedicle Probe Straight Left In Situ Bender Right In Situ Bender Instrument A Tray Assy. 1 Biomet Omega21 Instrument Case - B #28001 Catalog# Description Qty Torque Wrench, 6mm Torque Wrench, 9mm Locknut Driver, 6mm Soft Tissue Retractor mm Hex Wrench Cannulated T-Wrench, 9mm Compressor Compression Forceps Distraction Forceps 1 Biomet Omega21 Implant Case #28002 Catalog# Description Qty Multidirectional Coupler Multidirectional Slotted Coupler Locking Nut Transverse Rod Connector mm x 25mm Self-Tapping Screw mm x 30mm Self-Tapping Screw mm x 35mm Self-Tapping Screw mm x 40mm Self-Tapping Screw mm x 45mm Self-Tapping Screw mm x 50mm Self-Tapping Screw mm x 55mm Self-Tapping Screw mm x 30mm Self-Tapping Screw mm x 35mm Self-Tapping Screw mm x 40mm Self-Tapping Screw mm x 45mm Self-Tapping Screw mm x 50mm Self-Tapping Screw mm x 55mm Self-Tapping Screw mm x 60mm Self-Tapping Screw mm x 30mm Self-Tapping Screw mm x 35mm Self-Tapping Screw mm x 40mm Self-Tapping Screw mm x 45mm Self-Tapping Screw 8 25

28 Ordering Information (Continued) Biomet Omega21 Implant Case #28002 (Continued) Catalog# Description Qty mm x 50mm Self-Tapping Screw mm x 55mm Self-Tapping Screw mm x 60mm Self-Tapping Screw mm x 30mm Self-Tapping Screw mm x 35mm Self-Tapping Screw mm x 40mm Self-Tapping Screw mm x 45mm Self-Tapping Screw mm x 50mm Self-Tapping Screw mm x 55mm Self-Tapping Screw mm x 60mm Self-Tapping Screw mm x 30mm Spondy Screw mm x 35mm Spondy Screw mm x 40mm Spondy Screw mm x 45mm Spondy Screw mm x 50mm Spondy Screw mm x 55mm Spondy Screw mm x 30mm Spondy Screw mm x 35mm Spondy Screw mm x 40mm Spondy Screw mm x 45mm Spondy Screw mm x 50mm Spondy Screw mm x 55mm Spondy Screw mm x 30mm Spondy Screw mm x 35mm Spondy Screw mm x 40mm Spondy Screw mm x 45mm Spondy Screw mm x 50mm Spondy Screw mm x 55mm Spondy Screw mm x 35mm Expandable Screw mm x 40mm Expandable Screw mm x 35mm Expandable Screw mm Rod mm Rod mm Rod mm Rod 4 Biomet Omega21 Implant Case #28002 (Cont d) Catalog# Description Qty mm Rod mm Rod mm Rod mm Rod mm Rod mm Rod mm Rod mm Rod mm Rod mm Rod mm Rod mm Rod mm Rod mm Rod mm Rod mm Rod mm Rod mm Rod mm Rod mm Rod mm Transverse Rod mm Transverse Rod mm Transverse Rod 2 26

29 Biomet Omega mm Screw and Hook Case - #28003 Catalog# Description Qty mm x 25mm Self-Tapping Screw mm x 30mm Self-Tapping Screw mm x 35mm Self-Tapping Screw mm x 40mm Self-Tapping Screw mm x 45mm Self-Tapping Screw mm x 50mm Self-Tapping Screw Pedicle Hook Left Angled Hook Right Angled Hook Wide Laminar 6mm Hook Wide Laminar 8mm Hook Wide Laminar 10mm Hook Wide Reduced Laminar 6mm Hook Wide Reduced Laminar 8mm Hook Wide Reduced Laminar 10mm Hook Narrow Laminar 6mm Hook Narrow Laminar 8mm Hook Narrow Laminar 10mm Hook Narrow Reduced Laminar 10mm Hook Narrow Reduced Laminar 8mm Hook Narrow Reduced Laminar 6mm Hook Separate Hook Impactor Threaded Hook Inserter Wide Hook Starter Narrow Hook Starter Pedicle Hook Starter mm Reamer Probe Angled Hook Inserter Hook Forceps Sterilization Tray 1 Biomet Omega21 Revision Surgery Case - #28004 Catalog# Description Qty mm x 30mm Expandable Screw mm x 35mm Expandable Screw mm x 40mm Expandable Screw mm x 45mm Expandable Screw mm x 50mm Expandable Screw mm x 30mm Expandable Screw mm x 35mm Expandable Screw mm x 40mm Expandable Screw mm x 45mm Expandable Screw mm x 50mm Expandable Screw Bone Planner mm Hex Wrench 1 Biomet Omega21 Cross Connector Case - #28005 Catalog# Description Qty mm - 36mm Telescoping, 2 Angulating Cross Connector mm - 42mm Telescoping, 2 Angulating Cross Connector mm - 52mm Telescoping, 2 Angulating Cross Connector mm - 72mm Telescoping 2 Angulating Cross Connector mm Fixed, 2 Angulating Cross Connector mm Fixed, 2 Angulating Cross Connector mm Fixed, 2 Angulating Cross Connector mm Fixed, 2 Angulating Cross Connector Cross Connector Holder Transverse Link Torque Wrench 1 27

30 Indications For Use The Biomet Omega21 System is a single use spinal fixation device for pedicle screw fixation and a nonpedicle hook and sacral/iliac screw fixation system of the noncervical spine. When used as a pedicle screw fixation system, in the non-cervical spine of skeletally mature patients, the System is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusionin the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocations, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). Contraindications Biomet Omega21 is contraindicated in patients with spinal infection or inflammation; morbid obesity; mental illness; alcoholism or drug abuse; pregnancy; metal or foreign body sensitivity; inadequate tissue coverage over the operative site; or open wounds near the operative area. In addition, when used as a pedicle screw fixation system in skeletally mature patients, it is intended for patients: a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; b) who are receiving fusion using autogenous bone graft only; c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and d) who are having the device removed after the development of a solid fusion mass. When used as a posterior hook and sacral/illiac screw fixation system, the levels of attachment are the lumbar and thoracic spine, and screw fixation limited to the sacrum and ilium. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudarthrosis, stenosis, scoliosis, spondylolisthesis, fracture, previous failed fusion, or tumor resection. When used as an anterior fixation system, the levels of attachment are the anterolateral vertebral bodies of the lumbar and thoracic spine. The System is intended for the treatment of degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), pseudarthrosis, stenosis, scoliosis, spondylolisthesis, fracture, previous failed fusion, or tumor resection. 28

31 Warnings 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. 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. Sterilization Recommendations The Biomet Omega21 Spinal Fixation System is provided nonsterile and must be sterilized prior to use. All packaging materials must be removed prior to sterilization. The following steam sterilization parameters are recommended. Cycle: High Vacuum Temperature: 270 F / 132 C Time: 8 Minutes Note: Allow for cooling Individuals or hospitals not using the recommended method, temperature or time are advised to validate any alternative methods or cycles using an approved method or standard. 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 system because this is a technically demanding procedure presenting a risk of serious injury to the patient. See the Warnings, Precautions, and Possible Adverse Effects sections of the package insert for a complete list of potential risks. 29

32 Further Information This brochure describes the surgical technique used by Mark Crawford, M.D. Biomet Spine, as the manufacturer of this device, does not practice medicine and does not recommend this product or any specific surgical technique for use on any individual patient. The surgeon who performs any implant procedure is responsible for determining the appropriate product(s) and utilizing the appropriate technique(s) for said implantation in each individual patient. For further information, please contact the Customer Service Department at: Biomet Spine 100 Interpace Parkway Parsippany, NJ (973) (800)

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34 Notes: 32

35

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