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Universal Clamp—Surgical Technique Guide

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Summary of Contents for Universal Clamp

Page 1: ...Surgical Technique Guide Universal Clamp Spinal Fixation System Thoracolumbar Solutions ...

Page 2: ...2 Universal Clamp Surgical Technique Guide ...

Page 3: ...hensive training surgeons have received As with all surgical procedures the technique used in each case will depend on the surgeon s medical judgment as the best treatment for each patient Results will vary based on health weight activity and other variables Not all patients are candidates for this product and or procedure TABLE OF CONTENTS Implant Overview 4 Implant Preassembly 5 Loop Preparation...

Page 4: ...yester band One locking screw Note The Universal Clamp diameter must match that of the rod to ensure proper biomechanical fixation DESCRIPTION 5 5mm Universal Clamp 6 0mm Universal Clamp 6 35mm 1 4 Universal Clamp DESCRIPTION 4 5mm Universal Clamp 4 75mm Universal Clamp 5 5mm Universal Clamp 6 0mm Universal Clamp 6 35mm 1 4 Universal Clamp Implant Sizes Stainless Steel Titanium ...

Page 5: ... jaw which is identified by the etched arrow then through the slot in the lower jaw STEP 1B The band is gently pulled through the slots until reaching the end of the band with two metallic buckles Note Titanium alloy and stainless steel Universal Clamp implants must not be in contact with any osteosynthesis devices made of non compatible materials Mixing metals such as titanium and stainless steel...

Page 6: ...ection and preferably near the midline under the spinous process Caution During band passage maintain upward pressure on the malleable leader to ensure the band stays in contact with the anterior aspect of the lamina and does not push or bow into the dura Warning Additional fixation is required at the cephalad and caudal ends of the construct in scoliosis surgery especially in case of obesity extr...

Page 7: ...o band passage Band passers are not used to pass the band under the lamina Do not twist the band during band passage maneuvers and take care when passing the band near the thecal sac STEP 2 OPTION 2A Transverse Process Band For Use in Adult Patients Requires Universal Clamp Instrument Kit SNA027 0008 PL Transverse process band passage is warranted where additional bony fixation is desired Passage ...

Page 8: ...asser To pass the band insert the band passer into the eyelet near the tip of the band Contour the malleable leader to the band passer STEP 2 OPTION 2C Band Threading Use the band passer with the handle lateralized in a rotating motion to thread the band through the passage created by the elevator ...

Page 9: ...t pass the tip through the lower jaw and then proceed to the upper jaw of the clamp Pass the band s tip through both buckles and loop back through only one buckle tighten to create a working loop Use the buckle to adjust the working loop s size as needed Ensure reduction capability by having twice as much leader length in the soft band area between the buckle and leader Adjust the working loop siz...

Page 10: ...e arrowetchedontheUniversalClampimplantisvisible andpointingtowardthemid lineofthespinalcolumn STEP 4B Lock Universal Clamp Implant Ensure the jaw with the directional arrow is loaded in the up or dorsal orientation Assemble the clamp to the rod by introducing a locking screw Ti blue stainless steel shiny metallic gray with the tapered screw starter Initiate the locking screw a few turns for impla...

Page 11: ...ightened using the reduction tool The modular reduction tool is assembled by snapping the reduction tool handle to the reduction tool barrel STEP 5B Modular Reduction Tool Disassembly The reduction tool can be disassembled by depressing the side button on the connection between the handle and barrel Side Button ...

Page 12: ...around the capture post of the reduction tool squeeze the reduction tool s handle This action lengthens the working loop and shortens the anatomic loop of the band Partially tightening each clamp successively in several stages reduces stress on the individual vertebrae and optimizes the correction Note Ensure that the buckle on the soft band does not contact the capture post during reduction If it...

Page 13: ...ive purposes Note Sequential tightening of multiple Universal Clamps in the construct is recommended to achieve a smooth correction STEP 7 Final Tightening When the intended correction or the maximal recommended tension is reached use the 3 5mm final screwdriver to final tighten the Universal Clamp implant The reduction tool may then be removed by depressing the button at the back of the reduction...

Page 14: ...d to eliminate frayed ends Perform wound closure in the usual manner To remove the Universal Clamp System use the 3 5mm final screwdriver to loosen and remove the locking screw and take the metal jaws off the rod Cut the band close to the cephalad and caudal ends of the lamina Gently massage the band back and forth a few millimeters to ensure no adherence with the lamina or dura Gently pull the ba...

Page 15: ...S Universal Clamp Band SN2027 0 20000 SNA027 0 20000 Universal Clamp Locking Screw Titanium Alloy SN2027 0 20006S SNA027 0 20006S Universal Clamp 4 5mm Titanium Alloy SN2027 0 20045 Universal Clamp 4 75mm Titanium Alloy SN2027 0 20047 Universal Clamp 5 5mm Titanium Alloy SN2027 0 20055 SNA027 0 20055 Universal Clamp 5 5mm Clamp Titanium Alloy SN2027 0 20155 SNA027 0 20155 Universal Clamp 6 0mm Tit...

Page 16: ...ner PART NUMBER SN2027 1 02600 Final Screwdriver 3 5mm PART NUMBER SN2027 1 02570 Reduction Tool PART NUMBER Reduction Tool Barrel SN2027 1 02200 Reduction Tool Handle SN2027 1 02201 Bengolea Forceps PART NUMBER 20cm SN2027 1 02270 26cm SN2027 1 02276 Tapered Screw Starter PART NUMBER SN2027 1 02512 ...

Page 17: ...d not be used for sublaminar passage Only included in Universal Clamp Instrument Kit SNA027 0008 PL Prepare a pathway around the transverse process through which to pass the Universal Clamp System s polyester band Elevator 45 Right PART NUMBER SN2027 1 02102 Elevator 90 Left PART NUMBER SN2027 1 02101 Elevator 45 Left PART NUMBER SN2027 1 02103 Elevator 90 Right PART NUMBER SN2027 1 02100 Elevator...

Page 18: ...cluded in Universal Clamp Instrument Kit SNA027 0008 PL Draw the Universal Clamp System s polyester band through the prepared pathway around the transverse process Band Passer 45º Right PART NUMBER SN2027 1 02112 Band Passer 45º Left PART NUMBER SN2027 1 02113 Band Passer 90º Left PART NUMBER SN2027 1 02111 Band Passer 90º Right PART NUMBER SN2027 1 02110 SUPPORTING INSTRUMENTATION AND IMPLANTS co...

Page 19: ... SPINAL FIXATION SYSTEM Thisdevicecomponentisnotimplanted Contraindications The Universal Clamp System is not designed or sold for any use except as indicated DO NOT USE THE UNIVERSAL CLAMP IMPLANTS IN THE PRESENCE OF ANY CONTRAINDICATION Contraindications include but are not limited to Active systemic infection or infection localized to the site of the proposed implantation Severe osteoporosis is...

Page 20: ...precautions Preoperative Never use titanium titanium alloy and or cobalt chromium with stainless steel in the same implant construct otherwise galvanic corrosion may occur Intraoperative Insertion of an implant must be done using the instruments designed and supplied for this purpose and the technique specific to each device The details of this insertion are found in the Universal Clamp System Sur...

Page 21: ...sensitivity or allergic reaction to a foreign body 4 Infection 5 Foreign body reaction to the implants including possible tumor formation 6 Pain discomfort or abnormal sensations due to the presence of the device 7 Pressure on the skin from component parts where there is inadequate tissue coverage over the implant causing skin irritation 8 Loss of proper spinal curvature correction height and or r...

Page 22: ...22 Universal Clamp Surgical Technique Guide NOTES ...

Page 23: ......

Page 24: ...nginformation seethepackageinsertandwww zimmerbiomet com 2016 Zimmer Biomet Spine Inc All rights reserved All content herein is protected by copyright trademarks and other intellectual property rights as applicable owned by or licensed to Zimmer Biomet Spine Inc or its affiliates unless otherwise indicated and must not be redistributed duplicated or disclosed in whole or in part without the expres...

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