CSLP Variable Angle For Use with the Cervical Spine Locking Plate System TECHNIQUE GUIDE Self-drilling Screw Variable Screw Angulation Original Instruments and Implants of the Association for the Study of Internal Fixation AO/ASIF
Technique Options Implant Selection page 4 Unicortical Screw Purchase Bicortical Screw Purchase Self-Drilling Screws Self-Tapping Screws Bicortical Screws Variable Medial Angulation page 5 Variable Medial Angulation page 6 Bicortical Screw Purchase page 8 Lock Construct page 10 Self-Drilling Screws Self-Tapping Screws Bicortical Screws 12 mm 14 mm 16 mm 12 mm 14 mm 16 mm 18 mm 19 mm 20 mm
Table of Contents Features........................................... 2 Technique Implant Selection and Preparation.................... 4 Self-Drilling Screws Variable Medial Angulation....................... 5 Self-Tapping Screws Variable Medial Angulation....................... 6 Bicortical Screw Purchase Technique Using Bicortical Screws................. 8 Lock Construct Insert Locking Screws............................ 10 Product Information Instruments.................................... 11 CSLP Instrument Set............................. 15 CSLP Variable Angle Plates......................... 16 CSLP Screws....................... Inside Back Cover
CSLP Variable Angle The CSLP Variable Angle is designed to ease the surgical technique and increase system versatility, while maintaining the mechanical properties of the existing Cervical Spine Locking Plate. 1 Level 2 Level 3 Level 4 Level Variable Screw Angulation The screw can be angulated in any direction and still lock to the plate. This provides the stability and load sharing needed to allow bony fusion. The locking mechanism relies on the expansionhead screws, which have been proven effective in over 150,000 procedures. Self-Drilling Screws Self-drilling screws make drilling unnecessary. They have the same pull-out strength as selftapping and standard screws of the same size. 12 mm 14 mm 16 mm 2 The Synthes Anterior CSLP System including the Small Stature Anterior Cervical Vertebrae Plate System consists of plates with and Locking Screws. The plate attaches to the anterior portion of the vertebral body of the cervical spine. The CSLP system listed systems are intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications: spondylolisthesis, fracture, spinal stenosis, and tumor.
CSLP Variable Angle (continued) Additional Features Pre-lordosed plates Back surface of plate textured to reduce slippage Longer screw lengths allow bicortical screw purchase Available for 1-, 2-, 3- and 4-level corpectomies and discectomies A notch at each end of the plate allows space for pins when used to compress the graft. Bicortical screws (green) 18 mm, 19 mm, 20 mm Compatible with CSLP Variable Angle Standard 4.0 mm Cortex Screws 4.35 mm Cancellous 12 mm 14 mm 16 mm 18 mm 19 mm 20 mm Self-Tapping 4.0 mm Cortex Screws 4.0 mm Cancellous 4.35 mm Cancellous 4.5 mm Cancellous Self-Drilling 4.0 mm Cortex Screws 4.0 mm Cancellous 4.5 mm Cancellous Recommended for use Not available 3
Technique Implant Selection and Preparation 1 Select and insert graft Following approach and decompression, measure for graft, using the Caliper [324.06]. Insert the graft. For recommended grafting technique, refer to the Synthes ACF Spacer Technique Guide. 324.06 Measure for graft size using Caliper [324.06]. 2 Select plate Select a template of the estimated length. Place it on the vertebral body to determine plate length and screw position relative to the endplates. After plate length has been determined, ensure that the pre-lordosed plate fits the anatomy. Plate contour can be adjusted by using the Universal Bending Pliers [387.293] Note: Repeated bending may weaken the plate. Note: Before inserting the plate, ensure that all bushings are in the correct position (the countersunk hole and four slots of the bushing should be visible from the top of the plate). Determine plate length using template [350.xxx]. 387.293 Increase lordotic bend Decrease lordotic bend Bushing allows variation of screw angle. 4
Technique Using Self-Drilling Screws With Variable Medial Angulation Steps 1 and 2 are shown on page 4. 3 Place plate 387.282 Using the Plate Holder [387.532], place the plate in the desired position on the vertebral body. 387.532 387.595 387.595 If desired, hold the plate in place with a Temporary Fixation Pin [387.595]. The pin can be inserted with the Self-Retaining Screwdriver for expansionhead screws [387.282]. Place plate and insert Temporary Fixation Pin [387.595]. Temporary Fixation Pin 4 Break cortex Insert the Awl [387.291] through the bushing in the desired screw trajectory and break the cortex. Push to stop (10 mm). The Awl centers the screw hole in the plate. Tip of awl 387.291 5 Insert self-drilling expansionhead screws Load the appropriate length self-drilling screw onto the Self-Retaining Screwdriver for expansionhead screws. Insert the screw through the plate hole in the desired direction, until the head is seated in the bushing. Note: The head of the screw will be flush with the top surface of the bushing. Remove the temporary fixation pin and insert the remaining expansionhead screws. Break cortex using 387.282 the Awl. Insert self-drilling expansionhead screw. 6 Lock construct Insert locking screws as described on page 10. Insert remaining expansionhead screws. 5
Technique Using Self-Tapping Screws With Variable Medial Angulation Steps 1 and 2 are shown on page 4. 3 Place plate Insert the Single Locking Drill Guide [387.286] into the screw hole and squeeze the handles to lock it to the plate. Next slide the thumb-latch forward to keep the guide locked in place. Place the plate on the vertebra. If desired, hold the plate in place with a Temporary Fixation Pin [387.595]. The pin can be inserted with the Self-Retaining Screwdriver for expansionhead screws [387.282]. 387.286 Insert Single Locking Drill Guide into screw hole. 387.286 Squeeze handle, then slide thumb-latch forward. 387.282 387.595 Push forward Place plate and insert Temporary Fixation Pin [387.595]. 4 Drill Angulate the drill guide in the desired direction and drill, using a silver-colored 3.0 mm Drill Bit [324.12 324.16] of the appropriate length. Release the thumb-latch and remove the drill guide. 324.12 324.16 Pull back Drill using a 3.0 mm drill bit [324.12 324.16]. To remove Single Locking Drill Guide from plate: Squeeze handle, pull thumb-latch back and release the handle. 6
Self-Tapping Screws With Variable Medial Angulation (continued) 5 Insert self-tapping expansionhead screw Insert a self-tapping expansionhead screw with the Self-Retaining Screwdriver for expansionhead screws [387.282]. If desired, or when using non self-tapping screws, the drilled hole may be tapped using the appropriate tap [387.276 387.279]. 387.282 Insert self-tapping expansionhead screw. Remove the Temporary Fixation Pin. Drill the remaining screw holes and insert the expansionhead screws. Insert remaining expansionhead screws. 6 Lock construct Insert locking screws as described on page 10. 7
Technique Using Bicortical Screws Steps 1 and 2 are shown on page 4. 3 Place plate Insert the Single Locking Drill Guide [387.286] into the screw hole and squeeze the handles to lock it to the plate. Slide the thumb-latch forward to keep it locked in place. Place the plate on the vertebra. 387.286 Push forward If desired, hold the plate in place with a Temporary Fixation Pin [387.595]. The pin can be inserted with the Self-Retaining Screwdriver for expansionhead screws [387.282]. Insert Single Locking Drill Guide into screw hole. 387.286 Squeeze handle, then slide thumb-latch forward. 387.282 387.595 Place plate and insert Temporary Fixation Pin [387.595]. 4 Drill Drill to the desired depth, using the 3.0 mm Drill Bit for Bicortical Screws [387.275]. Confirm position under imaging. Release the thumb-latch and remove the drill guide. 387.275 Pull back Drill using the bicortical drill bit. To remove Single Locking Drill Guide from plate: Squeeze handle, pull thumb-latch back and release the handle. 8
Bicortical Screws (continued) 5a Select screw Use the Cervical Depth Gauge [387.292] to measure for screw length. Read the length from the depth gauge and select the expansionhead screw of the same length. 387.292 Note: Length indicated on the depth gauge is the same as expansionhead screw length. Measure for screw length. 5b Insert expansionhead screw Insert the selected bicortical expansionhead screw using the Self-Retaining Screwdriver. 387.282 Remove the Temporary Fixation Pin. Drill remaining holes, measure and insert the remaining expansionhead screws using the same technique. 6 Lock construct Insert locking screws as described on page 10. Insert self-tapping expansionhead screw. Drill remaining screw holes through the drill guide, measure, and insert remaining expansionhead screws, using the same technique. 9
Lock Construct 6 Insert locking screws Use the Self-Retaining Screwdriver for locking screw [387.284] to insert the 1.8 mm Locking Screws [497.78] into the expansionhead screws. The locking screw expands the flanges of the expansionhead screw, which expands the bushing and locks the screw in the plate. Note: To obtain the most rigid construct, the Countertorque Wrench [324.067] should be used with the Self-Retaining Screwdriver for locking screw to provide countertorque during insertion and tightening of the locking screw. The tips of the countertorque wrench fit into the slots of the expansionhead screw head. 387.284 497.78 Insert the locking screws. Final construct 10
Instruments Single Locking Drill Guide [387.286] Used as drill guide, and as a plate holder. With CSLP Variable Angle, it also allows variable screw angulation in all planes. 3.0 mm Drill Bit with stop, 12 mm 16 mm [324.12, 324.14, 324.16] (silver) For use with the Single Locking Drill Guide [387.286]. Caution: These drill bits should not be used with the Drill and Screw Guide [387.288], as they do not provide a safety stop. Awl for self-drilling screws [387.291] Used to center the screw hole in the plate and to break the near cortex. Tip of awl Cervical Depth Gauge [387.292] For determining the correct length of bicortical screws. 11
Instruments (continued) 3.0 mm Drill Bit for Bicortical Screws [387.275] For use only with CSLP Variable Angle. Note: This drill bit has a safety stop of 20 mm when used with the Single Locking Drill Guide [387.286]. Caliper [324.06] For sizing graft. Plate Lifter [324.066] For lifting CSLP plates out of modules [304.975, 304.976, 304.978, 304.984, 304.985]. Temporary Fixation Pin [387.595] Holds any Cervical Spine Locking Plate securely to the bone prior to final placement of screws. Compatible for use with Self-Retaining Screwdriver, for expansionhead screws [387.282]. Countertorque Wrench [324.067] Used with the Self-Retaining Screwdriver for locking screw [387.284] to provide countertorque to the expansionhead screw during insertion and tightening of a locking screw. Note: Do not use for insertion and removal of expansionhead screws. 12
Taps [387.276 387.279] Used to tap drilled holes for expansionhead screws. Self-Retaining Screwdriver, for expansionhead screws [387.282] For insertion of expansionhead screws. May also be used to insert the Temporary Fixation Pin [387.595]. Self-Retaining Screwdriver, for locking screw [387.284] For inserting the locking screw into the expansionhead screw. Universal Plate Bender [387.293] For contouring of CSLP plates. Caution: Repeated bending will weaken plate. Increase lordotic bend Decrease lordotic bend 13
Instruments (continued) Cervical Plate Holder [387.532] Holds any CSLP plate during insertion and fixation. Handle with quick coupling [311.43.99] For use with drill bits and conical extraction screw. Conical Extraction Screw [387.34] For removal of an expansionhead screw, if necessary. 14
Cervical Spine Locking Plate Instrument Set [105.897] CSLP Graphic Case 690.028 Instruments 324.06 Caliper 324.067 Countertorque Wrench 324.12 3.0 mm Drill Bit with Stop, 12 mm, 2 ea. 324.14 3.0 mm Drill Bit with Stop, 14 mm, 2 ea. 324.16 3.0 mm Drill Bit with Stop, 16 mm, 2 ea. 387.276 Tap for 4.0 mm Cortex 387.277 Tap for 4.0 mm Cancellous 387.282 Self-Retaining Screwdriver for expansionhead screws, 2 ea. 387.284 Self-Retaining Screwdriver for locking screw, 2 ea. 387.286 Single Locking Drill Guide 387.291 Awl for Self-Drilling 387.293 Universal Plate Bender 387.34 Conical Extraction Screw 387.532 Plate Holder 387.595 Temporary Fixation Pin for use with screwdriver, 3 ea. 311.43.99 Handle with quick coupling, 2 ea. 690.028 CSLP Graphic Case Also Available 324.061 Locking Drill Guide with Tissue Protection Sleeve 324.065 Cervical Plate Bender 324.066 Plate Lifter 387.20 3.0 mm Drill Guide 387.278 Tap for 4.35 mm Cancellous 387.279 Tap for 4.5 mm Cancellous 387.292 Cervical Depth Gauge 387.275 3.0 mm Drill Bit for Bicortical Screws 15
CSLP Variable Angle Implant Set [105.894] Module Case for 1-,2-, and 3-Level Plates [304.984] Module Case for 4-level Plates [304.985] Plate Lifter for CSLP [324.066] Cephalad to Overall caudal hole pair length length (mm) (mm) One-Level Plates 450.151 14 23 450.152 16 25 450.153 18 27 450.154 20 29 450.155 22 31 450.156 24 33 450.157 26 35 Two-Level Plates 450.161 28 37 450.162 31 40 450.163 34 43 450.164 37 46 450.165 40 49 450.166 43 52 450.167 46 55 Cephalad to Overall caudal hole pair length length (mm) (mm) Four-Level Plates 450.181 60 69 450.182 64 73 450.183 68 77 450.184 72 81 450.185 76 85 450.186 80 89 450.187 84 93 450.188 88 97 450.189 92 101 450.190 96 105 450.191 100 109 Three-Level Plates 450.171 45 54 450.172 48 57 450.173 51 60 450.174 54 63 450.175 57 66 450.176 60 69 450.177 63 72 450.178 66 75 450.179 69 78 Implants are commercially pure (CP) titanium Set also includes corresponding templates [350.151.191] 16
CSLP Screws CSLP Screw Module [304.983] (Holds six Screw Rack Inserts) Standard 4.0 mm Cortex 450.012 12 mm 487.04 14 mm 450.016 16 mm 4.35 mm Cancellous 451.012 12 mm 488.814 14 mm 451.016 16 mm Locking Screw 497.78 1.8 mm Self-Drilling 4.0 mm Cortex 450.137 12 mm 450.138 14 mm 450.139 16 mm 4.0 mm Cancellous 450.131 12 mm 450.132 14 mm 450.133 16 mm 4.5 mm Cancellous 450.144 12 mm 450.145 14 mm 450.146 16 mm Self-Tapping 4.0 mm Cortex 487.042 12 mm 487.044 14 mm 487.046 16 mm 4.0 mm Cancellous 450.134 12 mm 450.135 14 mm 450.136 16 mm 4.35 mm Cancellous 487.052 12 mm 487.054 14 mm 487.056 16 mm Screw Rack Insert shown with screws Screw Rack Inserts (must be ordered separately) For Standard 304.983T1 4.0 mm Cortex 304.983T6 4.35 mm Cancellous Also Available 304.981 Module case for CSLP Standard Plates 5, 8 and 9 holes For Self-Drilling 304.983T3 4.0 mm Cancellous 304.983T5 4.0 mm Cortex 304.983T9 4.5 mm Cancellous 4.5 mm Cancellous 450.141 12 mm 450.142 14 mm 450.143 16 mm 450.147 18 mm 450.148 19 mm 450.149 20 mm 4.0 mm Cortex, for bicortical use* 450.127 18 mm* 450.128 19 mm* 450.129 20 mm* For Self-Tapping 304.983T2 4.0 mm Cortex 304.983T4 4.0 mm Cancellous 304.983T7 4.35 mm Cancellous 304.983T8 4.5 mm Cancellous * Longer lengths for bicortical purchase may be stored in flip-up screw rack of module.
SYNTHES Spine 1302 Wrights Lane East West Chester, PA 19380 Telephone: (610) 719-5000 To order: (800) 523-0322 Fax: (610 ) 251-9056 SYNTHES (CANADA) LTD. 2566 Meadowpine Boulevard Mississauga, Ontario L5N 6P9 Telephone: (905) 567-0440 To order: (800) 668-1119 Fax: (905) 567-3185 Original Instruments and Implants of the Association for the Study of Internal Fixation AO/ ASIF 2000 SYNTHES Spine SYNTHES and ASIF are trademarks of SYNTHES (USA). Printed in U.S.A. Rev. 7/06 J3173-D