SURGICAL TECHNIQUE GUIDE
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- Duane Lynch
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1 The following general surgical technique is for illustrative purposes only. As with all surgical procedures, the technique used in each case will depend on the surgeon s medical judgment as to the best treatment for each patient. Detailed pre-operative planning is essential. Preoperative diagnostic evaluation followed by carefully executed surgical technique is required. Only those individuals with specialized training and experience in spinal surgery should attempt use of the Lanx Concero Facet Screw System. Refer to the IFU (LIT CE) for a detailed list of indications, contraindications, warnings, cautions and other information about the system. Surgical Access and Patient Positioning Surgical site access is dependent upon the level and indication(s) being treated. Adequate planning should be done to ensure safe and proper access to the surgical site. Included in this planning, pre-operative imaging studies of the anatomy should be examined to ensure that the range of implant sizes is appropriate for the patient anatomy at the levels to be implanted. The surgeon must verify that the available implant sizes are appropriate to fit the patient s anatomy at the operative levels, prior to commencing surgery. The patient is subsequently placed in the proper position (prone) to accommodate the desired surgical approach. Preparation of Implant Site After access to the surgical site is complete, ensure the correct level has been exposed via C-arm fluoroscopy or other suitable imaging methods. Once verified, perform the necessary bony preparation as dictated by the present pathology. Page 1 of 7
2 Surgical Implantation Proper placement is established by locating the appropriate anatomic landmarks. Lateral View The starting point of the facet screw should be at the transition of the pars interarticularis and the inferior articular process and be approximately in line with the inferior endplate of the superior vertebra. The trajectory is across the facet joint and into the inferior pedicle. AP View The starting point of the facet screw should be at the transition of the pars interarticularis and the inferior articular process and be approximately in line with the medial border of the inferior pedicle. The trajectory is laterally directed, through the center of the inferior pedicle. To help establish and maintain trajectory, a K-wire may be placed at the proper location described above. This will also facilitate the use of a minimally invasive approach, relative to an open procedure. Page 2 of 7
3 If a minimally invasive (MI) approach is desired, the surrounding tissue is retracted utilizing stepped dilators placed over the K-wire. If a K-wire has been placed, use the Cannulated Drill ( ) to drill a hole at the desired trajectory, otherwise the Non-Cannulated Drill ( ) can be used for drilling. Cannulated Drill with MI approach. Standard Drill Page 3 of 7
4 Use either the Cannulated Tap ( ), if a K-wire has been placed or the Non-Cannulated Tap ( ) after drilling. Cannulated Tap Standard Tap Using the Facet Screw Driver ( ), drive the screw along the established trajectory until the head of the screw is fully seated on the bone. (NOTE: The Facet Screw Driver is cannulated to fit over the K-wire if necessary.) Non-Cannulated Screw Cannulated Screw Final Position Page 4 of 7
5 Repeat the above steps on the contralateral side to establish a bilateral construct. Upon completion of the implantation, inspect the construct to ensure that it is properly placed and the screws are tightened down completely. Lateral/anterior images may be obtained to confirm proper placement. Close in a standard fashion for the approach used. Implant Removal The Lanx Concero Facet Screw System components can be removed if necessary. Removal is completed by using the Screw Driver to back the screws out. Page 5 of 7
6 Concero Surgical Case Contents Part Number Description Quantity Per Set See Page 8 Implants See Page Sterilization Case Cannulated Screw Caddie Non-Cannulated Screw Caddie mm Cannulated Drill Facet Screw Driver K-wire 0.062, 12 Length Cannulated, Double Lead Tap mm Non-Cannulated Drill Non-Cannulated, Double Lead Tap First Dilator Second Dilator Final Dilator Metal Final Dilator Radel Sounder, Flex Straight K-wire 19 length K-wire Dispenser shaft K-wire Holder Caps Jamshidi (11 gage 6 Trocar Tip) Ratcheting Med Axial Handle 2 Page 6 of 7
7 Implant Details & Sizing: Cannulated & Non-cannulated Lengths: 25mm 45mm (by 2.5mm increments) Lag screw with fixed thread length of 12mm Diameter: 4.5mm Washer Height: 4.75mm Washer Diameter: 11mm Cannulated, Double Lead, Fixed Lag Length Screws Part Number Diameter (mm) Length (mm) Quantity Per Set Non-Cannulated, Double Lead, Fixed Lag Length Screws Part Number Diameter (mm) Length (mm) Quantity Per Set Lanx, Inc. all rights reserved. Lanx, Surgeon Driven Innovation, Concero and other associated designs and logos are registrations or trademarks for Lanx, Inc. Important: Review the instructions for use for a list of warnings, cautions, contraindications, risks and product description. Page 7 of 7
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