Top Loading System Click X. A posterior pedicle screw fixation system.

Transcription

1 Top Loading System Click X. A posterior pedicle screw fixation system. Technique Guide Instruments and implants approved by the AO Foundation

2 Table of Contents Introduction Click X System 2 Indications 3 Surgical Technique Prepare Pedicles and Insert Pedicle Screws 4 Prepare Site and Attach 3-D Head 5 Select and Insert Rod 6 Place Rod Pusher and Insert Locking Caps 7 Tighten Set Screws and Perform Lordotic Compression 8 Compression/Distraction with Fixed 3-D Heads 9 Product Information Implants 10 Instruments 11 Set List 14 Synthes Spine

3 Click X System Self-tapping Screws Double-lead thread for easy insertion 3-D Head 3-D Head offers 25 of angulation about the axis of the screw Polyaxial freedom of 3-D Head allows the implant to readily adjust to the rod Top-loading for easy rod introduction Compression or distraction can be accomplished with the 3-D Head either fixed or mobile Locking Cap Freely rotating guiding forks align the locking cap with the rod. This feature, combined with precisely engineered instruments, ensures proper alignment and prevents cross-threading. Curved Rods Curved rods reduce or eliminate the need to contour while maintaining the same mechanical properties as straight rods.* *Data on file at Synthes. 2 Synthes Spine Top Loading System Click X Technique Guide

4 Indications The Synthes USS are noncervical 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. In addition, Synthes USS 6.0 mm rod systems can be interchanged 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 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 When used with the 3.5 mm/ 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 mm/ 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 mm/ 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 mm/6.0 mm and 4.0 mm/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 mm/5.5 mm and 4.0 mm/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 mm/6.0 mm tapered rods, the Synthes USS 6.0 mm rod systems can be linked to the MATRIX System. Synthes Spine 3

5 Prepare Pedicles and Insert Pedicle Screws 1 Prepare pedicles Instruments Pedicle Probe, for 7.0 mm, 8.0 mm and 9.0 mm screws (4.8 mm) Probe (3.8 mm) Awl Locate and expose the pedicles. Using the pedicle awl, open the cortex of the pedicles to a depth of 10 mm. Continue opening the pedicles using the probe, with markings at 30 mm, 40 mm, and 50 mm to determine the appropriate length of the 6.2 mm titanium Click X pedicle screws. Note: If inserting 7.0 mm titanium Click X pedicle screws, use the 4.8 mm pedicle probe. 2 Insert pedicle screws Instruments mm Hexagonal Screwdriver with T-Handle Click X Holding Sleeve Using the 3.5 mm hexagonal screwdriver with T-handle and holding sleeve, insert the appropriate length self-tapping Click X pedicle screws into the prepared pedicles. 4 Synthes Spine Top Loading System Click X Technique Guide

6 Prepare Site and Attach 3-D Head 3 Prepare site for 3-D head Instrument Reamer, for Click X Pedicle Screws Place the reamer for Click X pedicle screws over the pedicle screw and remove excess bone around the screwhead. Use rotating movements until no more bone can be removed. Ensure there is enough space underneath and around the screwhead to allow the titanium 3-D head for titanium Click X screws to attach properly and avoid damage to the cranial and caudal joint. Repeat for each pedicle screw. 4 Attach 3-D head Instruments Positioning Holder Extraction Pliers Using the positioning holder, remove a 3-D head from the screw rack. Before clicking the 3-D head onto the pedicle screw, verify that the conical element (fuchsia ring) of the 3-D head is not pressed down. If the conical element is pressed down, it must be remobilized using the extraction pliers. See Step 10. conical element Note: Before inserting a rod, ensure each of the 3-D heads can move freely. If there is limited polyaxial movement, back out the screw assembly by turning counterclockwise until full range of motion is obtained. Synthes Spine 5

7 Select and Insert Rod 5 Select rod Instruments Coated Rod Template, for 6.0 mm rod Rod Bender Determine the correct rod contour and length using the 6.0 mm coated rod template. Select the appropriate length 6.0 mm titanium soft rod and, if necessary, contour the rod using the rod bender. 6 Insert rod Instrument Rod Holding Forceps Using the rod holding forceps, insert the rod into the 3-D heads. 6 Synthes Spine Top Loading System Click X Technique Guide

8 Place Rod Pusher and Insert Locking Caps 7 Place rod pusher on 3-D head Instrument Rod Pusher for Click X Press the rod into the 3-D head using the rod pusher for Click X. For constructs with two or more levels, it is recommended to begin with a central 3-D head. 8 Insert locking caps Instrument Screwdriver, for Titanium Click X Locking Cap Use the screwdriver for the titanium Click X locking cap to remove a locking cap from the screw rack. Ensure the screwdriver tongs fit firmly into the slots of the locking cap. With the rod pusher in place, insert the locking cap. Hand-tighten it on the 3-D head while counteracting torque with the rod pusher. The rod is now secured in the 3-D head. The 3-D head still retains its polyaxial flexibility. Note: Use of the rod pusher ensures correct alignment and prevents cross-threading of the locking cap. Repeat Step 7 and Step 8 for remaining pedicle screws. All locking caps on both sides of the construct must be inserted before continuing. Synthes Spine 7

9 Tighten Setscrews and Perform Lordotic Compression 9 Tighten setscrews Instrument mm Hexagonal Screwdriver with T-Handle Place the 3.5 mm hexagonal screwdriver with T-handle through the rod pusher. Tighten the setscrew and counteract torque with the rod pusher. Repeat for each 3-D head. 10 Compress with mobile 3-D heads (lordotic compression) Instrument Compression Forceps Compression with mobile 3-D heads is only possible if the 3-D head setscrews have not been tightened. Use the compression forceps to achieve compression, then tighten the setscrews as described in Step 9. 8 Synthes Spine Top Loading System Click X Technique Guide

10 Compression/Distraction with Fixed 3-D Heads Alternatively: Compress/distract with fixed 3-D heads (parallel manipulation) Instruments mm Hexagonal Screwdriver with T-Handle Screwdriver, for Titanium Click X Locking Cap Distraction Forceps, curved Compression Forceps Ensure all setscrews have been tightened as described in Step 9. Loosen the setscrew of the 3-D head to be adjusted. Place the screwdriver for the Click X locking cap on the assembly and insert the 3.5 mm hexagonal screwdriver with T-handle through the shaft of the screwdriver. Loosen the setscrew with the hexagonal screwdriver while counteracting torque with the screwdriver for Click X locking cap. This prevents the locking cap from loosening. Use the compression forceps to achieve compression, or distraction forceps to achieve distraction, then tighten the setscrews as described in Step 9. Repeat for each segment as required. Remobilize 3-D heads Instruments mm Hexagonal Screwdriver with T-Handle Rod Pusher for Click X Extraction Pliers The 3-D heads can be remobilized with the extraction pliers for Click X. Use the 3.5 mm hexagonal screwdriver with rod pusher to remove the locking caps. Remove the rod and insert the extraction pliers into the 3-D head and squeeze the handle closed completely (until arrows meet). Synthes Spine 9

11 Implants Click X Pedicle Screws Diameters of 6.2 mm (blue) and 7.0 mm (green) Self-tapping Double-lead thread 3-D Head 25 of angulation about the axis of the screw Top-loading Compression or distraction can be accomplished with 3-D Head either fixed or mobile Locking Cap Freely rotating guiding forks align Locking Cap with rod Curved and Straight Rods Curved rods reduce or eliminate the need to contour Straight rods in five lengths Low Profile Transconnector Curved rods reduce or eliminate the need to contour Straight rods in five lengths 10 Synthes Spine Top Loading System Click X Technique Guide

12 Instruments mm Hexagonal Screwdriver with T-Handle Long Small Hexagonal Screwdriver Positioning Holder, for Titanium 3-D Head Rod Pusher, for Click X Extraction Pliers, for Click X Screwdriver, for Titanium Click X Locking Cap Reamer, for Click X Pedicle Screws Synthes Spine 11

13 Instruments continued Holding Sleeve for Long Small Hexagonal Screwdriver Click X Holding Sleeve Distraction Forceps, curved Compression Forceps Rod Holding Forceps, for 6.0 mm Rods Bar Holding Forceps, for 3.5 mm Bar 12 Synthes Spine Top Loading System Click X Technique Guide

14 Pedicle Probe, for 7.0 mm, 8.0 mm and 9.0 mm screws Probe Awl Coated Rod Template for 6.0 mm Rod, 150 mm Rod Bender Synthes Spine 13

15 Top Loading System Click X ( ) Graphic Case Graphic Case, for Click X Top Loading System Instruments mm Hexagonal Screwdriver with T-Handle Long Small Hexagonal Screwdriver Positioning Holder, for Titanium 3-D Head Rod Pusher, for Click X Extraction Pliers, for Click X Screwdriver, for Titanium Click X Locking Cap, 2 ea Reamer, for Click X Pedicle Screws Holding Sleeve for Long Small Hexagonal Screwdriver Click X Holding Sleeve Distraction Forceps, curved Compression Forceps Rod Holding Forceps, for 6.0 mm Rods Bar Holding Forceps, for 3.5 mm Bar Pedicle Probe, for 7.0 mm, 8.0 mm and 9.0 mm screws Probe Awl Coated Rod Template for 6.0 mm Rod, 150 mm 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 DJ Synthes Spine Top Loading System Click X Technique Guide

16 Implants Titanium Low Profile Transconnectors, for 6.0 mm Rods, 2 ea. Length (mm) mm Titanium Click X Pedicle Screws Thread Length Qty. (mm) mm Titanium Click X Pedicle Screws Thread Length Qty. (mm) mm Titanium Curved Soft Rods, 4 ea. Length (mm) Titanium Click X Locking Cap, for Titanium 3-D Head, 10 ea Titanium 3-D Head, for Titanium Click X Screws, 10 ea. Also Available 6.2 mm Titanium Click X Pedicle Screws Thread Length (mm) mm Titanium Click X Pedicle Screws Thread Length (mm) mm Titanium Click X Pedicle Screws Thread Length (mm) mm Titanium Soft Rods, 4 ea. Length (mm) Synthes Spine 15

17 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, Click X, Pangea and Synthes are trademarks of Synthes, Inc. or its affiliates. Printed in U.S.A. 7/11 J3113-H