Medtronic RBT071555 Instructions for Use

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MAZORTM ROBOTIC GUIDANCE
PLATFORM TLIF PROCEDURE with
CD HORIZON™ MODULEX™ 5.5
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Table of Contents
Introduction and Surgical Overview 2
Instruments and Equipment 3
Navigated Instrument Verification 5
Cannula Placement 5
Drilling Pilot Holes 5
Tapping 6
Screw Shank Insertion 6
Tulip Head Attachment 8
Implant Explantation 8
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INTRODUCTION AND SURGICAL OVERVIEW
This technique describes the workflow for a MIS TLIF procedure using navigated robotic trajectory guidance. Surgeons should be familiar with the Mazor™ Robotic Guidance Platform and performing MIS TLIF procedures, per the surgical technique, before incorporating the robotic-guided navigated workflow into their practice.
Screw and Interbody Placement Sequence
To help ensure accurate screw placement adhere to the surgical sequence as follows:
1. Cannula Placement
2. Drill Pilot Holes
3. Tapping
4. Screw Shank Placement
5. Tulip Head Attachment
6. Implant Explantation
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INSTRUMENTS AND EQUIPMENT
FPO
FPO
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FPO
CD Horizon™ ModuLeX™
FPO
Robotic Guidance
CD Horizon™ ModuLeX™ Taps and Driver Set
Arm Guide
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NAVIGATED INSTRUMENT VERIFICATION
All NavLock™ trackers and navigated instruments may be verified with the Reference Frame on the sterile back table before the patient is in the OR.
CANNULA PLACEMENT
Insert the navigated Dilator into the Cannula. Insert the Cannula/ Dilator assembly into the Arm Guide. The Cannula must not touch the bone. Contact between the Cannula and the bone can cause the Cannula to slip and become misaligned. Be aware of soft tissue creep that may occur between the Cannula and the bone surface. When using a navigated instrument, it is recommended to periodically check accuracy. Do not retract the tapered Cannula such that the lasermarked line (at distal end of Cannula) may be visualized above the top-most surface of the Arm Guide. This ensures the Cannula maintains adequate engagement with the Arm Guide to preserve trajectory accuracy.
DRILLING
The pedicle must be cannulated by drilling a pilot hole prior to performing any of the subsequent steps to reduce the probability of skiving.
Pilot Hole Drilling Method - Midas Rex Drilling System Lightly place the Midas Rex™ drill system into the cannula such that the Midas dissecting tool is resting on the pedicle. If using navigation, verify the trajectory on the screen. Once confirmed, lift the Midas Rex™ drill system slightly off the pedicle, power the motor, and drive the dissecting tool into the pedicle with light forward motion to the appropriate depth.
Pilot Hole Drilling Method – IPC™ Powerease™ System Insert the Drill Guide into the Cannula. Align it within the Cannula and then let it slide in with its own momentum. Gently tap the top of the Drill Guide with the mallet to engage the Drill Guide teeth into the pedicle. Check that the Drill Guide is securely docked by applying gentle torque to the head.
Choose the appropriate size drill bit. Assemble the drill, driver handle, and NavLock™ Tracker then place the assembly through the Drill Guide Place the instrument assembly on the pedicle and verify the trajectory using navigation. Once confirmed, prepare the pilot holes in the desired trajectory. Tightly hold the top of the Drill Guide, then accelerate rotation of the drill bit while pressing the drill bit into the bone pilot hole with medium force.
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TAPPING
Tapping is optional, with the consideration of patient bone quality and planned trajectory angle, if using Awl-Tap Screws*. Remove the Midas Rex™ Drill System, leaving the Cannula in place. Attach the appropriate tap to either the IPC™ Powerease™ driver or manual Quick-Connect Ratcheting Handle. Do not mallet the IPC™ Powerease™ driver or the manual Quick-Connect Ratcheting Handle as this can damage the instrument and prevent removal of the NavLock™ tracker. Place the Tap through the Cannula and tap the depth to correlate to intended screw length. Undertap the pedicle by 0.5mm to
1.0mm of the final screw diameter. The depth lines/marks on the tap align with the top of the cannula to indicate an approximate tapping depth. Do not bottom out the tap on the top of the cannula as this will cause the tap to stop advancing and potentially damage the bone structure. Reorienting the field of view visualizes the articular process and capsule for placement of the caudal screw entry at the pole of the articular process.
SCREW SHANK PLACEMENT
For navigation to be accurate, the screw attached to the driver must be the same screw type, length, and diameter as planned in the navigation software. Thread the navigated driver into the head of the screw by turning the knob clockwise. When the screw is fully secured to the driver, the knob will not translate along the axis of the driver. The screw will not appear during navigation if the planned screw is not compatible with the driver selected for navigation.
Ensure the collet tip is fully exposed by turning the driver knob counterclockwise until resistance is felt. Select the appropriate screw shank diameter and length by both preoperative measurement and intraoperative observation. The screw diameter and length can be confirmed from labeling and/or using a screw confirmation gage. Place the driver hexalobe into the shank head, while in the tray. Slide collet over sphere, while maintaining engagement of the driver hexalobe in the shank head. Thread sleeve clockwise, until resistance is felt. Verify that the shank is properly attached to the driver.
Attach the screwdriver to either the IPC™ Powerease™ driver or manual Quick-Connect Ratcheting Handle. Insert the screw and screwdriver assembly through the arm guide. Slowly advance the implant down the pedicle to ensure proper tracking while allowing for viscoelastic expansion, being careful that the screw assembly is not advanced too far. The navigated screw should align with the planned screw. If the shank head is placed against the bone, the tulip head will not be able to be attached. Only advance the shank until the depth stop line reaches the bony anatomy. Advancing the screw all the way to the bone may also cause additional torque on the anatomy and robotic arm. Remove the driver from the
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screw by turning the knob counterclockwise. The knob should translate freely within the window to indicate the screw has disengaged from the driver. Repeat drilling, tapping, and screw shank placement steps for each level in the operating area.
If required, when all levels in the operating area are complete, expose the next surgical area and move the patient connection to the center of working area and repeat the registration workflow. Refer to the CD Horizon™ ModuLeX™ 5.5 Spinal System Surgical Technique for surgical steps following screw placement.
Helpful Hint
To confirm screw shank disengagement from the driver, turn the driver knob counterclockwise until indicator window turns completely black. This indicator window confirms driver disengagement prior to removal from the surgical site.
TULIP HEAD ATTACHMENT
To attach the tulip head to the head attachment tool pull up on the plunger to open the tool. This will allow the distal tabs to move out slightly and the laser mark will not be visible. Place the head attachment tool over the head. The head will bottom out on the top of the head and allow the inserter tabs to align with the head instrument notches. Move the slider downward to lock the head to the instrument and expose the laser mark band indicating correct attachment to the head. Align the head with the sphere of the screw shank. It is not required for the tulip head and screw shank to be in axial alignment as the head will attach from any angle. Gently push the head onto the sphere of the screw shank. If the head will not attach to the screw shank check that there is enough of the screw shank visible to attach the head. This can be accomplished by placing the reamer over the shank. If the black line is visible then the screw shank is appropriately placed. If the line is not visible there are two options
1) Back out the screw shank using the inner shaft from the reamer or 2) use the reamer to remove bone from around the shank. Pull up slightly on the attachment tool to confirm the head is provisionally attached to the shank. Turn the handle ¼ turn until the instrument clicks which indicates the head is locked onto the screw shank while the other hand is placed on the in-line handle to act as a countertorque to the rotation of the T-handle. Pull up the attachment tool plunger into the open position. Repeat the head attachment steps until all heads and screw shanks are assembled.
IMPLANT EXPLANTATION
To remove the set screws and the pedicle screw shanks, attach the obturator to the Break-Off Driver working end. Insert the obturator tip into the set screw and turn counterclockwise until the set screw is removed. To remove the screw shank and tulip, insert the obturator tip into the screw shank and turn counterclockwise until the tulip and screw shank is removed.
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