Dual-Opening USS. For deformity correction.

Transcription

1 Dual-Opening USS. For deformity correction. Technique Guide Instruments and implants approved by the AO Foundation

2 Table of Contents Introduction Dual-Opening USS 2 AO Principles 4 Indications 5 Preoperative Planning 6 Surgical Technique Hook Placement 7 Pedicle Preparation 10 Screw Insertion 13 Rod Contouring 15 Construct Assembly 18 Distraction and Compression 23 Final Construct Tightening 25 Transconnector Attachment 27 Transverse Bar Attachment (optional) 28 Anterior Approach 29 Product Information Implants 30 Instruments 32 Set List 39 Image intensifier control Synthes

3 Dual-Opening USS. For deformity correction. Goals of Scoliosis Surgery Correct sagittal and coronal alignment Restore balance in the spine Prevent further progression of deformity Fuse the fewest number of vertebral segments Protect the spinal cord The Dual-Opening USS is designed to achieve the goals of scoliosis surgery. The system is based upon: Independent anchorage of hooks and/or screws to the spine and independent rod positioning Simple connection between the implant and the rod Segmental correction and stabilization Preoperative Postoperative 2 Synthes Dual-Opening USS Technique Guide

4 Features and Benefits Low-profile system Dual-opening (side), top-tightening Reduces inventory Simplifies intraoperative procedure Technique adaptable Designed to correct scoliosis either by segmental translation or global derotation Versatile linkage mechanism Allows addition or removal of anchor points to an assembled construct Synthes 3

5 AO Principles In 1958, the AO formulated four basic principles, 1 which have become the guidelines for internal fixation. They are: Anatomic reduction Stable internal fixation Preservation of blood supply Early, active mobilization The fundamental aims of fracture treatment in the limbs and fusion of the spine are the same. A specific goal in the spine is returning as much function as possible to the injured neural elements. 2 AO Principles as Applied to the Spine 3 Anatomic alignment Restoration of normal spinal alignment to improve the biomechanics of the spine. Stable internal fixation Stabilization of the spinal segment to promote bony fusion. Preservation of blood supply Creation of an optimal environment for fusion. Early, active mobilization Minimization of damage to the spinal vasculature, dura, and neural elements, which may contribute to pain reduction and improved function for the patient. 1. M.E. Müller, M. Allgöwer, R. Schneider, H. Willenegger: Manual of Internal Fixation, 3rd Edition. Berlin; Springer-Verlag Ibid. 3. M. Aebi, J.S. Thalgott, J.K. Webb. AO ASIF Principles in Spine Surgery. Berlin; Springer-Verlag Synthes Dual-Opening USS Technique Guide

6 Indications The Synthes USS are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5). Pedicle screw fixation is limited to skeletally mature patients with the exception of the Small Stature USS, which includes small stature and pediatric patients. These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis, Scheuermann s Disease), tumor, stenosis, and failed previous fusion (pseudoarthrosis). When treating patients with Degenerative Disc Disease (DDD), transverse bars are not cleared for use as part of the posterior pedicle screw construct. Synthes USS 6.0 mm Rod Systems: USS Side-Opening, USS Dual- Opening, USS VAS variable axis components, USS Fracture, Click X, Click X Monoaxial, Pangea, Pangea Monoaxial, USS Polyaxial, USS Iliosacral, ClampFix 5.5 mm Rod System: Matrix 5.0 mm Rod System: USS Small Stature CerviFix 3.5 mm Rod Systems: CerviFix, Axon, Synapse 4.0 mm Rod System: Synapse Please refer to product insert GPOOO1 for complete system description, indications, contraindications, precautions and warnings. When used with the 3.5/6.0 mm parallel connectors, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm systems. In addition, when used with 3.5/5.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the CerviFix 3.5 mm systems. When used with the 5.0/6.0 mm parallel connectors, the Synthes Small Stature USS can be linked to the Synthes USS 6.0 mm rod systems. When used with the 3.5/6.0 mm and 4.0/6.0 mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the CerviFix 3.5 mm and 4.0 mm systems, respectively. When used with the 3.5/5.5 mm and 4.0/5.5 mm tapered rods, Matrix can be linked to the CerviFix 3.5 mm and 4.0 mm systems, respectively. When used with the 5.5/6.0 mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the Matrix System. In addition, Synthes USS 6.0 mm rod systems can be in terchanged with all USS 6.0 mm rods and transconnectors except Synthes 6.0 mm cobalt-chromium-molybdenum alloy and titanium grade 3 rods, which can only be used with Pangea. Synthes 5

7 Preoperative Planning Preoperative planning is critical in the preparation for spinal surgery. Dual-Opening USS Preoperative Planner A radiographic evaluation (AP and lateral standing, and AP and lateral bending) should be completed for proper diagnosis prior to surgical intervention. Additional evaluation, such as CT scans, may be required. Posterior View Dual-Opening Hooks * Lamina Hooks Tall Body Lamina Hooks Side-opening Front-opening Side-opening Front-opening x Small x x Small x Medium x x Medium x x Large x x Large x x A preoperative planner may be used to plan the hook and screw layout. Thoracic Lamina Hooks x99.276, Side-opening x99.277, Front-opening Angled Lamina Hooks x99.284, Side-opening x99.285, Front-opening Pedicle Hooks x99.278, Side-opening x99.279, Front-opening Right Left Transverse Process Hooks, Right x99.280, Side-opening x99.282, Front-opening Transverse Process Hooks, Left x99.281, Side-opening x99.283, Front-opening Dual-Opening Screws * 4.2 mm Screws Length x mm x mm x mm x mm x mm x mm x mm 7.0 mm Screws Length x mm x mm x mm x mm x mm x mm x mm x mm 5.2 mm Screws Length x mm x mm x mm x mm x mm x mm x mm 8.0 mm Screws Length x mm x mm x mm x mm x mm x mm x mm x mm x mm x mm x mm 6.2 mm Screws Length x mm x mm x mm x mm x mm x mm x mm x mm 9.0 mm Screws Length x mm x mm x mm x mm x mm x mm x mm x mm x mm x mm * Implants are available in both Stainless Steel and Titanium. Replace X with a 2 for Stainless Steel or 4 for Titanium. Illustrations not shown actual size. SYNTHES Spine 2002 Original Instruments and Implants of the Association for the Study of Internal Fixation AO/ASIF SYNTHES and ASIF are registered trademarks of SYNTHES (USA) and SYNTHES AG Chur. Printed in U.S.A GP1549A J3852A 6/02 6 Synthes Dual-Opening USS Technique Guide

8 Hook Placement 1a Prepare lamina for lamina hook Instrument Lamina Finder, for dual-opening hooks Use the lamina finder to separate the ligamentum flavum from the underside of the lamina to ensure good bony contact with the lamina hook. 1b Prepare pedicle for pedicle hook Instrument Pedicle Finder, for dual-opening hooks Using the pedicle finder, open the facet capsule and locate the pedicle. Remove a small piece of the inferior articular process to ensure proper seating of the pedicle hook (up-going only). Synthes 7

9 Hook Placement 2 Place hook Instruments Hook/ Screw Holder, with 4.0 mm hex ( Hex Stick ) Handle, for Hook/Screw Holder with 4.0 mm hex Hook Positioner, for dual-opening implants Insert the hook/screw holder ( Hex Stick ) into the appropriate hook and secure with the coupling screw. Snap the Hex Stick into the handle by depressing the button on the handle. Place the hook in the desired location. The hook positioner may also be used to facilitate placement of the hook. After the hook is properly seated, remove the handle. The Hex Stick can remain attached to the hook. 8 Synthes Dual-Opening USS Technique Guide

10 3 Place remaining hooks Repeat Steps 1 and 2 to place hooks at each hook site, as determined in the preoperative plan. Optional technique for hook placement Instrument Hook Holding Forceps, for dual-opening implants Attach the appropriate hook to the hook holding forceps and place the hook in the desired location. The hook positioner may be used to facilitate placement of the hook. After the hook is properly seated, remove the hook holding forceps and repeat hook placement at each hook site as determined in the preoperative plan. Synthes 9

11 Pedicle Preparation 1 Identify pedicles The point of entry for each thoracic pedicle is at the intersection of a line through the transverse process and a line through the inferolateral edge of the facet joint. The entry point for each lumbar pedicle is at the intersection of a horizontal line bisecting the transverse process and a vertical line drawn along the lateral border of the superior articular process. 10 Synthes Dual-Opening USS Technique Guide

12 2 Prepare pedicle Instruments Pedicle Probe, for 7.0 mm, 8.0 mm, and 9.0 mm screws or Pedicle Probe, for 5.2 mm and 6.2 mm screws or Pedicle Probe, for 4.2 mm screws Straight Ball Tip Probe or Curved Ball Tip Probe Awl, for 5.2 mm 9.0 mm screws or Awl, for 4.2 mm screws Use the awl to perforate the posterior cortex of the pedicle (Figure 1). Figure 1 Figure 2 Open the pedicle canal using the appropriate pedicle probe (Figure 2). Displace the soft cancellous bone by advancing the probe into the pedicle canal. Use radiographic imaging to check position and orientation. Care should be taken to not perforate the walls of the pedicle. Palpate the walls of the pedicle using a ball tip probe. Synthes 11

13 Pedicle Preparation 3 Select proper screw length Instruments Pedicle Marker, beaded Pedicle Marker, long beaded Place the ball tip probe into the pedicle canal to determine proper screw length. This instrument has depth markings at 25 mm, 30 mm, 40 mm, 50 mm, 60 mm, and 70 mm. Position all screws approximately 50 80% into the vertebral body. 4 Pedicle markers may be used during radiographic imaging to confirm position and orientation. 4. Müller, op cit. p Synthes Dual-Opening USS Technique Guide

14 Screw Insertion Screw insertion Instruments Hook /Screw Holder, with 4.0 mm hex ( Hex Stick ) Handle, for Hook/Screw Holder with 4.0 mm hex Insert the Hex Stick into the appropriate dual-opening screw and secure with the coupling screw. Snap the Hex Stick into the handle by depressing the button on the handle. Insert the dual-opening screw into the prepared pedicle. After the screw has been inserted, remove the handle by depressing the button, leaving the Hex Stick in place, if desired. Synthes 13

15 Screw Insertion Optional methods of screw insertion Instruments mm Hex Screwdriver mm Hexagonal Screwdriver Shaft Holding Sleeve, for Screwdriver for side-opening implant Ratchet Handle, with 5.0 mm drive The 4.0 mm hexagonal screwdriver may also be used for screw insertion. The ratchet handle, or handle for the hook/screw holder with 4.0 hex, used with the 4.0 mm hexagonal screwdriver shaft offers an alternative method for screw insertion. The holding sleeve may be used with either the screwdriver or the screwdriver shaft to retain the screw during initial insertion into the pedicle. 14 Synthes Dual-Opening USS Technique Guide

16 Rod Contouring 1 Determine rod contour Instruments Coated Rod Template for 6.0 mm Rod, 150 mm or Coated Rod Template for 6.0 mm Rod, 500 mm Once the screws and hooks have been placed and their positions confirmed radiographically, determine the contour of the rod by using the appropriate 6.0 mm coated rod template. Synthes 15

17 Rod Contouring 2 Cut rod to length (if necessary) Instruments Table Top Rod Cutter and Bender Handheld Rod Cutter, for 4.0 mm, 5.0 mm and 6.0 mm rods Adjust the rod length using the optional table top rod cutter or the handheld rod cutter. All rod cutting should take place outside the operative field. 16 Synthes Dual-Opening USS Technique Guide

18 3 Contour rod Instruments Rod Bender or Bending Iron, right, for 6.0 mm rods and Bending Iron, left, for 6.0 mm rods Contour the rod to match the rod template using the rod bender or the bending irons. Alternatively, the table top rod cutter and bender may be used to contour the rod. Synthes 17

19 Construct Assembly 1 Align rod to hooks and screws Instruments Rod Holding Forceps, for dual-opening implants Rod Pusher, for 6.0 mm rods Position the rod parallel to the side opening of the screws and hooks using the rod holding forceps. Introduce the rod into the side-opening screw or hook, using the rod pusher. 18 Synthes Dual-Opening USS Technique Guide

20 2 Apply collars and nuts Instruments Socket Wrench with Straight Handle, 11 mm, for 12-Point Nut Holding Sleeve, for Straight Handle Socket Wrench Assemble holding sleeve to the straight handled socket wrench. Load a collar and nut into the assembly by placing the wrench on top of the nut and collar, which have been stacked onto the loading posts in the graphic case. Advance the holding sleeve to engage the collar. Note: The collar can be loaded in only one direction. Place the instrument over the head of the implant and seat both the collar and the nut. Tighten the nut using the socket wrench. Synthes 19

21 Alternative Methods for Construct Assembly Option 1 Using the collar positioner with the Hex Stick Instruments Collar Positioner, for dual-opening implants Hook/ Screw Holder, with 4.0 mm hex ( Hex Stick ) Collar Impactor Load a collar for 6.0 mm rods into the collar positioner. Note: The collar can be loaded in only one direction. With the Hex Stick inserted in the hook or screw, place the loaded collar over the head of the implant to seat the collar. If light impaction of the collar is necessary for final seating, remove the collar positioner and use the collar impactor with a small mallet. Place a 12-point nut over the construct and tighten, using the socket wrench. Option 2 Using the Persuader with the Hex Stick 1 Load collar Instrument Collar Rod Introduction Pliers ( Persuader ), for dual-opening implants Load a collar onto the barrel of the rod introduction pliers ( Persuader ). Note: The collar can be loaded on the Persuader in only one direction. 20 Synthes Dual-Opening USS Technique Guide

22 2 Engage rod Instruments Distraction Forceps, curved Distraction Clip, side, for Hook/ Screw Holder Position the barrel of the Persuader over the Hex Stick and slide it down to the implant. Engage the rod with the jaws opposite the barrel of the Persuader and squeeze the handle to insert the rod into the hook or screw. If biplanar reduction of the rod is necessary, use the distraction clip and the distraction forceps with the Persuader to guide the rod into the hook or screw opening. Place the distraction clip over the Hex Stick. Use the distraction forceps against the distraction clip while squeezing the Persuader until the rod is seated into the hook or screw. Synthes 21

23 Alternative Methods for Construct Assembly 3 Seat collar Instruments Socket Wrench with L-Handle, 11 mm, for 12-Point Nut or Socket Wrench with Straight Handle, 11 mm, for 12-Point Nut Hook Positioner, for dual-opening implants Use the hook positioner to tap the collar retaining sleeve and seat the collar onto the implant assembly. Once the collar is pushed down over the implant, remove the distraction clip (if necessary) and the Persuader. Place a 12-point nut over the construct and tighten with the socket wrench. 22 Synthes Dual-Opening USS Technique Guide

24 Distraction and Compression If necessary, grasp the rod with the rod holding forceps and slowly rotate the rod in the proper direction. Make sure all nuts are loose before rotating the rod. 1 Determine point of fixation Instruments Rod Holding Forceps, for dual-opening implants / USS Half Ring (stainless steel or titanium) Use the rod holding forceps or half ring as a point of fixation, if necessary, against which to distract or compress. 2 If distraction is required Instruments Socket Wrench with Straight Handle, 11 mm, for 12-Point Nut Distraction Forceps, curved Use the distraction forceps for 6.0 mm rods. Make sure all nuts are loose before distracting against the point of fixation. Once in the desired position, tighten the nuts using a socket wrench. Synthes 23

25 Distraction and Compression 3 If compression is required Instruments Socket Wrench with Straight Handle, 11 mm, for 12-Point Nut Compression Forceps Use the compression forceps. Make sure all nuts are loose before compressing against the point of fixation. Once in the desired position, tighten the nuts using a socket wrench. 24 Synthes Dual-Opening USS Technique Guide

26 Final Construct Tightening The torque indicator wrench and socket adapter for torque indicator wrench can be used for final construct tightening. The torque indicator wrench and socket adapter are used with the 4.0 mm hexagonal screwdriver shaft and ratchet handle, which are used to apply countertorque. Option 1 Applying countertorque using the 4.0 mm hexagonal screwdriver Instruments Torque Indicator Wrench Adapter, 12 points, for Wrench with Torque Indicator mm Hexagonal Screwdriver Shaft Ratchet Handle Place the torque indicator wrench and adapter over the 12-point nut. Insert the 4.0 mm hexagonal screwdriver shaft with ratchet handle through the torque indicator wrench and adapter and into the hexagonal socket of the hook or screw. Hold the ratchet handle stationary and turn the torque indicator wrench clockwise to secure the nut. The torque indicator wrench deflects to indicate the desired torque. Recommended tightening is from 10 Nm to 12 Nm. The torque indicator wrench is calibrated to 12 Nm. The 4.0 mm hexagonal screwdriver can also be used to provide countertorque with the torque indicator wrench. Synthes 25

27 Final Construct Tightening Option 2 Applying countertorque using the 5 mm socket wrench and Hex Stick Instruments Socket Wrench with T-handle, 5 mm hex Socket Wrench with L-Handle, 11 mm, for 12-Point Nut Hook/ Screw Holder, with 4.0 mm hex ( Hex Stick ) Place the L-handle socket wrench over the Hex Stick and engage the 12-point nut. Insert the 5 mm T-handle socket wrench through the L-handle socket wrench to engage the 5 mm hex on the Hex Stick. Hold the T-handle wrench stationary and turn the L-handle socket wrench clockwise to secure the nut. 26 Synthes Dual-Opening USS Technique Guide

28 Transconnector Attachment The low profile transconnector is used as a construct stabilizer to reduce rotation. 1 Measure distance between rods Instrument Measuring Template, for Low Profile Transconnectors for 6.0 mm Rods Use the measuring template to measure the distance between the two rods. 2 Secure transconnector to rods Instrument Small Hexagonal Screwdriver Loosen all setscrews and place a low profile transconnector of the appropriate length onto the rods. Use the small hexagonal screwdriver to secure the transconnector to the rods by tightening the setscrews on each end. Note: For transconnectors with stargrind, tighten the stargrind setscrew to lock the angle between the rods. When using an adjustable length transconnector, adjust the distance between the rods, if desired, by compressing or distracting; then tighten the center setscrew on the rotating shaft using the small hexagonal screwdriver. Note: If any part of the construct requires further adjustment, all transconnector setscrews must be loosened. After final adjustment, retighten the setscrews. Synthes 27

29 Transverse Bar Attachment (optional) The transverse bar acts as an extension to the hook or screw in situations where the rod contour or patient anatomy prevents direct hook/ screw-to-rod connection. The bar lengths are 15 mm, 20 mm, and 25 mm. Placement of transverse bar Instruments Small Hexagonal Screwdriver Rod Pusher, for 6.0 mm rods Place the opening of the transverse bar over the 6.0 mm rod. Loosely attach the transverse bar to the rod by tightening the setscrew with the small hexagonal screwdriver. Introduce the transverse bar into the front-opening hook or screw. Use the rod pusher if necessary. Use a collar with grooves and a 12-point nut to secure the bar to the hook or screw. Secure the bar to the rod by tightening the setscrew firmly. 28 Synthes Dual-Opening USS Technique Guide

30 Anterior Approach Staples (5.0 mm, 6.0 mm, and 7.0 mm) and washers can be used to provide secure anchorage for anterolateral constructs. Insert staple Instruments Staple Impactor Collar Impactor For the 5.0 mm staple, use the collar impactor to seat the staple. For the 6.0 mm and 7.0 mm staples, use the staple impactor to position the staple on the anterolateral aspect of the thoracolumbar spine, to accommodate optimal screw placement. Drive the tips through the cortical bone and seat the staple using the impactor and a small mallet. Final construct Insert the screws through the staples or washers. Use the other implants (rod, collars, and nuts) to complete the construct. Synthes 29

31 Implants Hooks Dual-opening design allows rod attachment from either side of the hook Multiple hook profiles for use around the lamina, pedicle or transverse process Specialized lamina hooks for thoracic and lumbar applications Low-profile design to minimize soft tissue interference Pedicle hook Lamina hook Angled lamina hook Thoracic lamina hook Transverse process hook 11.5 mm Hard Rods 6.0 mm diameter 150 mm 500 mm lengths, in 50 mm increments Collars and Nuts Screws and hooks are secured to a 6.0 mm rod by collars and nuts Collars capture the rod, yet permit longitudinal adjustments along the rod before tightening Collars with grooves are available for use with transverse bars 12-point nuts secure the construct Collar 12-point nut Collar with grooves Screws Dual-opening design simplifies intraoperative rod-to-screw assembly Dual-core thread design Constant outer diameter optimizes pull-out strength Core diameter transitions to provide cancellous and cortical bone-specific threads Rounded tip promotes safe screw insertion Self-tapping tip Double-lead thread for easy insertion Available in 4.2 mm, 5.2 mm, 6.2 mm, 7.0 mm, 8.0 mm, and 9.0 mm diameters, and thread lengths from 25 mm to 80 mm 30 Synthes Dual-Opening USS Technique Guide

32 Low Profile Transconnectors Used as a construct stabilizer to reduce rotation Preassembled for ease of placement Available in four fixed lengths (15 mm, 18 mm, 21 mm, and 24 mm) and five adjustable lengths (25.5 mm 83 mm) Adjustable length Fixed length Center shaft allows 45 rotation about the horizontal axis Stargrind Transverse Bars Provide a lateral extension from the 6.0 mm rod to the hook or screw Used with screws and front-opening hooks Available in lengths of 15 mm, 20 mm and 25 mm Eliminate the need for severe rod contours which might otherwise be required for direct hook/screw-to-rod connection Parallel Connectors The 6.0 mm/6.0 mm Parallel Connector is available for extending Dual-Opening USS constructs The 5.0 mm/ 6.0 mm Parallel Connector allows attachment to Small Stature USS constructs The 3.5 mm/6.0 mm Parallel Connector permits attachment of the Dual-Opening USS to the CerviFix System (available in titanium only) 6.0 mm/6.0 mm 5.0 mm/6.0 mm 3.5 mm/6.0 mm Staples and Washers Provide secure anchorage for anterolateral constructs in the thoracolumbar spine Three sizes of staples for use with 5.2 mm, 6.2 mm and 7.0 mm screws Synthes 31

33 Instruments Taps for Dual Core Screws mm mm mm mm mm mm Cannulated Taps for Dual Core Screws mm mm mm mm mm mm Small Hexagonal Screwdriver Bending Irons, for 6.0 mm rods, right left Staple Impactor, for 6.0 mm 8.0 mm staples 32 Synthes Dual-Opening USS Technique Guide

34 Torque Indicator Wrench Socket Wrench with T-Handle, 5 mm hex Collar Positioner, for dual-opening implants Socket Wrench with L-Handle, for 12-point nut Socket Wrench, for 12-point nut Adapter, 12-points, for Wrench with Torque Indicator Synthes 33

35 Instruments Holding Sleeve, for Straight Handle Socket Wrench Universal Spinal System Tap Handle mm Hexagonal Screwdriver mm Hexagonal Screwdriver Shaft USS Holding Sleeve, for Pre-Assembled Transconnector Clamp Holding Sleeve, for Screwdriver for side-opening implants 34 Synthes Dual-Opening USS Technique Guide

36 Distraction Forceps, curved, for 6.0 mm rods Compression Forceps, for 6.0 mm rods Rod Holding Forceps, for 6.0 mm rods Rod Introduction Pliers, for dual-opening implants ( Persuader ) Synthes 35

37 Instruments Pedicle Finder, for dual-opening hooks Lamina Finder, for dual-opening hooks Hook Holding Forceps, for dual-opening implants Pedicle Probes For 7.0 mm, 8.0 mm, and 9.0 mm screws For 5.2 mm and 6.2 mm screws For 4.2 mm screws Ball Tip Probes Straight Curved Awl For 5.2 mm 9.0 mm screws For 4.2 mm screws 36 Synthes Dual-Opening USS Technique Guide

38 Pedicle Markers beaded long beaded Hook/Screw Holder, with 4.0 mm hex ( Hex Stick ) Distraction Clip, side, for hook/ screw holder Handle, for hook/ screw holder with 4.0 mm hex Hook Positioner, for dual-opening implants Ratchet Handle Synthes 37

39 Instruments Collar Impactor Measuring Template, for Low Profile Transconnector for 6.0 mm Rods Coated Rod Templates for 6.0 mm Rod mm mm Rod Pusher, for 6.0 mm rods Rod Bender, with bend radius adjustment 38 Synthes Dual-Opening USS Technique Guide

40 Dual-Opening USS Instrument and Implant Sets Stainless Steel ( ) and Titanium ( ) Graphic Case Graphic Case for Dual-Opening USS Rod Instrument Set Instruments Small Hexagonal Screwdriver Bending Iron, right, for 6.0 mm rods Bending Iron, left, for 6.0 mm rods Staple Impactor, for 6.0 mm 8.0 mm staples Torque Indicator Wrench Socket Wrench with T-Handle, 5 mm hex Collar Positioner, for dual-opening implants, 2 ea Socket Wrench with L-Handle, 11 mm, for 12-Point Nut Socket Wrench with Straight Handle, 11 mm, for 12-Point Nut, 2 ea Adapter, 12-points, for Wrench with Torque Indicator Holding Sleeve, for Straight Handle Socket Wrench, 2 ea USS Holding Sleeve, for Pre-Assembled Transconnector Clamp Distraction Forceps, curved Compression Forceps Rod Holding Forceps, for dual-opening implants, 2 ea Rod Introduction Pliers ( Persuader ), for dual-opening implants, 2 ea Distraction Clip, side, for Hook/ Screw Holder, 2 ea Collar Impactor Measuring Template, for Low Profile Transconnectors for 6.0 mm Rods Coated Rod Template for 6.0 mm Rod, 150 mm, 2 ea Coated Rod Template for 6.0 mm Rod, 500 mm, 2 ea Rod Pusher, for 6.0 mm rods Rod Bender Note: For additional information, please refer to package insert. For detailed cleaning and sterilization instructions, please refer to or to the below listed inserts, which will be included in the shipping container: Processing Synthes Reusable Medical Devices Instruments, Instrument Trays and Graphic Cases DJ1305 Processing Non-sterile Synthes Implants DJ1304 Synthes 39

41 Dual-Opening USS Instrument and Implant Sets Stainless Steel ( ) and Titanium ( ) Graphic Case Graphic Case for Dual-Opening USS Hook and Screw Instrument Set Instruments Tap for Dual Core Screws mm mm mm mm mm mm Cannulated Tap for Dual Core Screws mm mm mm mm mm mm Universal Spinal System Tap Handle mm Hex Screwdriver mm Hex Screwdriver Shaft Holding Sleeve, for Screwdriver for side-opening implants Pedicle Finder, for dual-opening hooks Lamina Finder, for dual-opening hooks Hook Holding Forceps, for dual-opening implants, 2 ea. Pedicle Probes For 7.0 mm, 8.0 mm, and 9.0 mm screws For 5.2 mm and 6.2 mm screws For 4.2 mm screws Straight Ball Tip Probe Curved Ball Tip Probe Pedicle Marker, beaded, 5 ea Pedicle Marker, long beaded, 5 ea Hook/ Screw Holder, with 4.0 mm hex ( Hex Stick ), 16 ea Handle, for Hook/Screw Holder with 4.0 mm hex, 2 ea Hook Positioner, for dual-opening implants Ratchet Handle, with 5.0 mm drive Awl For 5.2 mm 9.0 mm screws For 4.2 mm screws 40 Synthes Dual-Opening USS Technique Guide

42 Graphic Case Graphic Case for Dual-Opening USS Hook and Rod Implant Set Implants Small Lamina Hooks, dual-opening Stainless Steel Titanium Description Qty side frontal 2 Medium Lamina Hooks, dual-opening Stainless Steel Titanium Description Qty side frontal 2 Large Lamina Hooks, dual-opening Stainless Steel Titanium Description Qty side frontal 2 Thoracic Lamina Hooks, dual-opening Stainless Steel Titanium Description Qty side frontal 2 Pedicle Hooks, dual-opening Stainless Steel Titanium Description Qty side frontal 2 Transverse Process Hooks, dual-opening Stainless Steel Titanium Description Qty side, right side, left frontal, right frontal, left 2 Synthes 41

43 Dual-Opening USS Instrument and Implant Sets Stainless Steel ( ) and Titanium ( ) Implants continued Angled Lamina Hook, dual-opening Stainless Steel Titanium Description Qty side frontal 2 Small Tall Body Lamina Hooks, dual-opening Stainless Steel Titanium Description Qty side frontal 2 Medium Tall Body Lamina Hooks, dual-opening Stainless Steel Titanium Description Qty side frontal 2 Large Tall Body Lamina Hooks, dual-opening Stainless Steel Titanium Description Qty side frontal mm Hard Rods Stainless Steel Titanium Length (mm) Qty Point Nut Stainless Steel Titanium Length (mm) Qty Low Profile Transconnectors, for 6.0 mm rods Stainless Steel Titanium Length (mm) Qty Parallel Connectors, 2 ea. Stainless Steel Titanium Length (mm) / / / mm Transverse Bars, 2 ea. Stainless Steel Titanium Length (mm) Collars for 6.0 mm Rods Stainless Steel Titanium Description Qty With Grooves 4 42 Synthes Dual-Opening USS Technique Guide

44 Graphic Case Graphic Case for Dual-Opening USS Screw Implant Set Implants Dual-Opening Screws Dia. Thread Stainless Steel Titanium (mm) Length (mm) Qty Washers, 4 ea. Stainless Steel Titanium For Screw Dia. Outer Dia Staples, 4 ea. Stainless Steel Titanium for 5.2 mm screws for 6.2 mm screws for 7.0 mm screws Synthes 43

45 Also Available Dual-Opening USS Implant Set Dual-Opening USS Instrument Set Dual-Opening USS Titanium Implant Set Nm Torque Limiting Wrench Ratchet T-Handle, 6 mm hex coupling Table Top Rod Cutter and Bender Handheld Rod Cutter, for 4.0 mm, 5.0 mm and 6.0 mm rods USS Preassembled Transconnector Clamp Stainless Steel Titanium USS Half Ring, for 6.0 mm rods Stainless Steel Titanium Low Profile Transconnectors, for 6.0 mm rods Stainless Steel Titanium Length (mm) Dual-Opening Screws* Stainless Steel Titanium Thread Dia. Length (mm) * May be stored in Graphic Case Synthes Dual-Opening USS Technique Guide

46 Synthes Spine 1302 Wrights Lane East West Chester, PA Telephone: (610) To order: (800) Fax: (610) Synthes (Canada) Ltd Meadowpine Boulevard Mississauga, Ontario L5N 6P9 Telephone: (905) To order: (800) Fax: (905) Synthes, Inc. or its affiliates. All rights reserved. CerviFix and Synthes are trademarks of Synthes, Inc. or its affiliates. Printed in U.S.A. 5/11 J3985-G