Medtronic 4680005 Technical Manual

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2021

Prone Lateral Single-Position
Procedure
with Mazor™ Robotic Guidance
Platform

Interbody Options

Anteralign™ TL Spinal System with Titan nanoLOCK™ Surface Technology

Fixation

CD Horizon™ Solera™ Voyager™ 4.75 and 5.5/6.0mm System

DIRECTIONS FOR USE Rev 1.0 M333023W352

MEDTRONIC

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Contents

Introduction and Surgical Overview ................................................................................................................. 3

Instruments and Equipment .............................................................................................................................. 4

Preoperative Planning ........................................................................................................................................ 5

Registration Workflow Selection ....................................................................................................................... 6

Equipment and Room Setup ............................................................................................................................. 7

Navigated Instrument Verification .................................................................................................................... 7

Bed Frame Attachment ................................................................................................................................... 10

Patient Positioning ........................................................................................................................................... 10

Mounting the Surgical System ........................................................................................................................ 11

Sterile Draping ................................................................................................................................................. 12

Reference Frame Placement ........................................................................................................................... 12

Attaching the Bone Mount Platform to Bony Anatomy ................................................................................ 13

3Define Scan .................................................................................................................................................... 15

Navigation Registration ................................................................................................................................... 16

Registration....................................................................................................................................................... 16

Accuracy Check ................................................................................................................................................ 18

Pedicle Access Preparation ............................................................................................................................ 19

Drilling and Tapping ........................................................................................................................................ 21

Screw Insertion ................................................................................................................................................. 24

Transition from Robotic Guidance Navigation to Freehand Navigation.................................................... 26

Disconnecting Bone Mount ............................................................................................................................ 26

DLIF Interbody Procedure .............................................................................................................................. 27

Localization ....................................................................................................................................................... 29

DLIF Site Access ............................................................................................................................................... 29

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Disc Preparation ............................................................................................................................................... 31

Trial Insertion .................................................................................................................................................... 32

Interbody Placement/Closure ........................................................................................................................ 33

Rod/Set Screw Insertion .................................................................................................................................. 33

Confirmation Image Acquisition (Optional) .................................................................................................. 34

Removing the Surgical System ....................................................................................................................... 34

Implant Explantation ........................................................................................................................................ 34

Appendix A: PSIS Reference Frame Option ................................................................................................. 35

Appendix B: Hybrid Guidewire Option ......................................................................................................... 36

Appendix C: Scan and Plan Workflow ........................................................................................................... 37

Introduction and Surgical Overview

This technique describes the workflow for the prone position DLIF procedure supplemented with
bilateral pedicle fixation using 3-D operative imaging and navigated robotic trajectory guidance.

Surgeons should be familiar with the Mazor™ Robotic Guidance Platform and performing Direct
Lateral Interbody Fusion procedures per the DLIF surgical technique before incorporating the robotic­guided navigated workflow into their practice.

Screw and Interbody Placement Sequence

To help ensure accurate screw placement in addition to navigation enabled placement of an interbody
device, adhere to the surgical sequence as follows:

1. Imaging and registration

2. Pedicle preparation

3. Screw placement

4. Interbody placement

5. Rod and set screw placement

Other devices referenced in this document:

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Anteralign™ Spinal System with Titan nanoLOCK™ Surface Technology

CD Horizon™ Solera™ Voyager™ 4.75 and 5.5/6.0mm System (PMD008700-2.0)

Mazor X Stealth™ Edition User Manual (Manual Document Number: TSD0114-01)

Navlock™ Tracker (Manual Document Number: 9734289)

NOTE: Additional instructions included in the applicable navigated instruments IFU/eManual

referenced above

Midas Rex™ Drill System

IPC™ Powerease™ System

O-arm® Imaging System User Manual (Manual Document Number: BI-500-00060)

Grafton DBF™ Inject

Synergy DLIF™ Technique (UC202002542 EN)

Synergy OLIF25™ Technique

Synergy Prone Lateral Single-Position Workflow (Manual Document Number: UC202114331EN)

Consult instructions for use included with the product and/or at this website

www.medtronic.com/manuals.

Instruments and Equipment

Mazor™ Robotic Guidance Platform

IPC™ Powerease™ System

Midas Rex™ Drill System

NIM-Eclipse™ Spinal System

Anteralign™ TL Spinal System

Navigated Anterolateral Disc Preparation Instruments

Navigated Lateral Disc Preparation instruments

OLIF25™ Retractor

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Consult the Mazor™ and O-arm™ Imaging System manuals for complete indications, warnings,

precautions, important medical information, and instruction on equipment and OR set-up, reference

frame placement, and registration.

Preoperative Planning

The Mazor™ Robotic Guidance Platform gives surgeons the ability to plan preoperatively when a
computer tomographic (CT) scan is acquired prior to surgery. This can be useful so that planning does
not need to be performed intraoperatively after registration. For shorter constructs, both preoperative
planning with a CT scan or intraoperative planning during a Scan and Plan procedure are options.

Preoperative planning is enabled using the patient’s 1mm-cut CT helical scans of the surgical field
utilizing the Mazor CT protocol. These images allow visualization of the bony anatomy and disc height
and are used during the preoperative planning procedure to determine the appropriate plans for
screw placement, biopsy, osteotomy, or other trajectories.

The CT scans are uploaded to the Mazor™ Robotic Guidance System and the planning software
provides tools and optimized views of the anatomy to design a construct customized to the patient
anatomy and alignment goals. The surgeon can accurately plan trajectories (entry point and path) and
select optimal screw dimensions. The software also has alignment tools such as Cobb, Axial Rotation,
and ruler measurements, as well as skin incision planning capabilities. The plan is then used
intraoperatively after the fluoroscopic registration steps for robotic guidance of associated
instruments.

The surgeon can also utilize the planning software to make decisions about interbody implant
selection, sizing, position, and simulate how the interbody may impact spinal alignment.

Note

Disc preparation and interbody insertion steps are not completed with robotic guidance. Navigation
guidance may be used, however navigating to the planned interbody implant location is not available
The user may save a projection of the shaver or trial and navigate the interbody to the saved position.

Depending upon surgeon preference, the preoperative planning procedure may be performed either
remotely (on a PC or laptop computer), or on the Mazor™ Robotic Guidance Platform Workstation.

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Helpful Hint

Utilize the instrument trajectory projection during planning to help identify potential interference with
bony structures during along the insertion pathway, such as Illiac Crest

Helpful Hint

When planning screw entry points on steeper surfaces, making the entry point orthogonal to the
anatomy may minimize intraoperative skiving. If it is not possible to achieve a plan that avoids high
entry point angles resulting in skive potential, prepare a flat surface at least the diameter of the dilator.

Preoperative Planning

Preoperative sagittal and axial MRI should be used to determine whether a patient is suitable
for the DLIF procedure. Reference appropriate DLIF surgical techniques for more information on
vascular and other patient considerations.

Other preoperative considerations such as spinopelvic parameter measurements and patient
morphology should also be considered when determining patient suitability for the DLIF procedure

with application of bilateral pedicle fixation in the prone position.

Registration Workflow Selection

There are two intraoperative registration workflows available when using the Mazor™ Robotic
Guidance Platform. For detailed instructions on the two workflows, refer to the Mazor X Surgical
Technique Guide. For in-depth use of the software, refer to the detailed instructions provided in the
Mazor X Stealth Edition™ User Manual.

Mazor X CT-to-Fluoro Workflow

This is the standard workflow, based on pre-operative CT-to-Fluoro image registration.

Navigation has been disabled for posterior bony decompression instruments when using CT-to-Fluoro
registration because there may be diminished navigation accuracy for some posterior bony anatomy.
This includes the Stealth-Midas™ Legend and MR8 Systems, the 1/4" Posterior Osteotome, and the
1/2" Posterior Osteotome. To enable these instruments, please perform a Scan and Plan registration.

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Mazor X Scan and Plan Workflow

This is the workflow applicable when using an intraoperative 3-D imaging device such as the O-arm™
Imaging System. For instructions specific to the Scan and Plan registration workflow, refer to Appendix
C.

Equipment and Room Setup

Bring the Mazor™ Robotic Guidance Platform into the room. Position the navigation camera at the
head end of the patient table so that the camera will have an unobstructed line-of-sight to the patient
reference frame once it is placed.

Helpful Hint

The camera can also be positioned to the side of the head of the table with the arm extended to reach
toward the center of the head of the table.

Ensure the Mazor™ Robotic Guidance Platform Image Adaptor is attached to the C-arm following the
instructions in the Mazor X Surgical Technique Guide. A 12-inch C-arm is recommended over a 9-inch
C-arm in order to register a larger anatomical segment.

As the scrub technician is setting up the instrument table, they should check the interface of mating
components to ensure there is no sticking, binding, or grinding between the critical interfaces
including:

• Arm guide and scalpel handle

• Arm guide and outer cannulas

• Arm guide and drivers

• Outer cannula and dilator

• Outer cannulas and taps

• Outer cannulas and Midas Rex™ Attachment

Navigated Instrument Verification

Helpful Hint

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The Medtronic consultant will be provided with a Navigation Code to enable the navigation of
approved implant systems.

From the Home screen in the software, tap the Setup Process function button, then select Instrument
Setup from the dropdown menu. The instruments are categorized into multiple groups. Choose the
desired Patient Reference Frame to add it to the procedure Tool Card pane. Note that only one
Reference Frame can be added into a procedure at a time.

Attach the Spheres to the reference frame from the Patient Reference Set. Attach the spheres to the
NavLock™ Trackers from the Stealth Navigation Tracker Set and the Midas Rex™ Drill System. Press
the Spheres onto the trackers until they snap into place and then check to ensure they are secure.
Next, attach the NavLock™ Trackers to the instruments.

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.

Place the tip of each instrument into the divot on the Patient Reference Frame. Hold the instrument
perpendicular and visible to the navigation camera until confirmation is received. Use the tracking view
in the lower right of the instrument setup screen to ensure the camera is tracking the Reference Frame
and instruments.

• Successful verification is indicated by a chime.

• Failed verification is indicated by a negative “bonk” and indicates that the instrument may be

positioned improperly in the divot or is bent/damaged. Inspect the instrument; if it is
bent/damaged, do not use.

• If no sound is heard when the instrument tip is placed into the divot, this may indicate that the

camera cannot see either the instrument or the reference frame. Or the instrument is not in the
procedure.

Helpful Hint

Instruments may only be verified in the Reference Frame divots. Instruments cannot be verified using
the arm guide accuracy checkpoint.

Helpful Hint

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Passive spheres may become coated with fluid or debris during use, hindering their ability to reflect
light. If this occurs, wipe away the debris with a soft, sterile cloth (the cloth may be wet, but make sure
to dry each sphere thoroughly). Keep extra spheres available as replacements during a case.

Important

Passive spheres are a single-use disposable product and should not be preprocessed. Do not
reprocess, re-sterilize, or reuse any single-use device.

Helpful Hint

Assigning an instrument to a specific-colored NavLock™ Tracker will eliminate the need to switch the
tracker from one instrument to the next throughout the procedure. As an example, the grey tracker
could be assigned to the dilator and the orange tracker could be assigned to the short driver.

Helpful Hint

To simplify NavLock™ Tracker verification, you can verify all NavLock™ Trackers using the dilator.
Following verification, assign the NavLock™ Trackers to the desired instruments.

Helpful Hint

All Mazor™ Robotic Guidance Platform instrumentation (excluding the Midas Rex™ Drill System)
intended for long solution heights are color-coded with gold for easy identification. Midas Rex™
attachment sizes are denoted by “SHORT” or “LONG” text markings on the attachments as well as a
magenta color band on the Long and a teal color band on the Short.

Important

Due to the longer length of certain instruments or instrument-implant combinations, use of the Black
or Blue NavLock™ Trackers may be required. This requirement is typically for long drivers in
combination with screws 55mm or longer. Refer to the chart below for information.

Instrument/Implant Combinations which Require NavLock™ Black or NavLock™ Blue

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Refer to the desired interbody section for implants-specific instructions on how to verify relevant
instruments.

Note

CD Horizon™ Ballast™ System taps should be used for screw lengths greater than 60mm and/or
diameters greater than 7.5mm.

Note

During planning, select the appropriate screw system to activate the extender-related functionality.
When using CD Horizon™ Solera™ Voyager™ screws with extender tabs, the system will default to
longer trajectories which may require the long instrumentation to avoid collision with the extender
tabs.

Bed Frame Attachment

Attach the Bed Frame Adaptor to the bed following instructions in the Mazor X Stealth Edition™ User
Manual.

Helpful Hint

Confirm that the orientation of the bed frame allows for the surgical system to be mounted on the
appropriate side of the table per the surgeon’s preference.

Patient Positioning

The surgeon should consider ease of access, surgeon preference, and preoperative images when
determining approach.

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Place the patient in the prone position, lying flat on a Jackson spine top table. The patient should be
secured to the surgical table with tape across chest and hips, ensuring that the PSIS and Patient
Reference Frame incision location is not covered.

Helpful Hint

Helpful Hint

While positioning and draping patient, ensure enough clearance for DLIF site access.

Important

Patient stability is critical to ensuring accuracy.

Important

Patient positioning should be finalized before registration.

Mounting the Surgical System

Once the Bed Frame Adaptor attachment is complete and the patient is on the table, the surgical
system can be mounted onto the Bed Frame Adaptor. The Mazor™ Robotic Guidance Platform
mounting procedure is performed with the aid of the Manipulator, an on-board automated lifting
mechanism stored within the Mazor™ Robotic Guidance Platform Workstation. The mounting
procedure is performed in the three steps listed below.

• Place the Manipulator/Surgical System in the launch position

• Mount the Surgical System onto the Bed Frame Adaptor

• Return the Manipulator to the parked position

For detailed instructions on mounting the surgical system onto the Bed Frame Adaptor, refer to the
Mazor X Stealth Edition™ User Manual.

The navigation camera should be positioned at the head of the OR table with an unobstructed line-of­sight to the Reference Frame.

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Sterile Draping

Refer to the Surgical Sterile System Drape instructions on sterile draping provided in the Mazor X
Disposable Kit.

Important

Be careful to attach the correct arm guide. Use the Arm Guide and Arm Guide Screw associated with
the navigated implant system being used. Refer to the reference below to determine the appropriate
guide for the procedure.

Helpful Hint

Be sure to position the surgeon monitor in the surgeon's preferred location before draping the
surgical system.

Arm Guide Reference

RG 4.75mm Arm Guide

• CD Horizon™ Solera™ 4.75mm Fixed Angle Screw

• CD Horizon™ Solera™ 4.75mm Multi-Axial Screw

• CD Horizon™ Solera™ 4.75mm Reduction Multi-Axial Screw

• CD Horizon™ Solera™ Voyager™ 4.75mm Screw

• CD Horizon™ Solera™ Voyager™ 4.75mm Multi-Axial Awl-Tap Screw

RG 5.5/6.0mm Arm Guide

• CD Horizon™ Solera™ 5.5/6.0mm Fixed Angle Screw

• CD Horizon™ Solera™ 5.5/6.0mm Sagittal-Adjusting Screw

• CD Horizon™ Solera™ 5.5/6.0mm Multi-Axial Screw

• CD Horizon™ Solera™ Voyager™ 5.5/6.0mm Screw

• CD Horizon™ Solera™ Voyager™ 5.5/6.0mm Multi-Axial Awl-Tap Screw

• CD Horizon™ Solera™ 5.5/6.0 Multi-Axial Reduction Screw

Reference Frame Placement

When performing a Prone Lateral Single-Position procedure use of the Spinous Process Clamp with
the Small Passive Reference Frame is recommended. The clamp should be firmly attached to the

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spinous process superiorr to the planned instrumented levels. With the camera positioned at the
patient’s head, the clamp should be within an unobstructed view of the camera and the instruments.

Note: The Stealth Air Frame could be used instead of the Small Passive Reference Frame.
Alternatively, the Percutaneous Reference Pin with the Percutaneous Reference Frame can be used.
Please refer to instructions in Appendix A.

Attaching the Bone Mount Platform to Bony Anatomy

Refer to the Mazor™ X Surgical Technique Guide for all bone mount platform options.

For DLIF procedure, the Schanz Screw is recommended. A powered hand drill is used to place the
Schanz Screw into the PSIS. The Schanz Screw must be inserted into the PSIS via a posterior incision.

Insert the Schanz Screw

Make a stab incision over the PSIS at the desired insertion site. Ensure that the incision enables access
to the iliac crest where the Schanz Screw will be placed. Load the Schanz Screw onto a pin driver. Drill
into the PSIS bone through the incision. The pin should be oriented perpendicular to the floor. Ensure

enough pin is visible above the patient’s skin to fully engage the Schanz Connector, or other bone

mount connection. Test for rigidity to ensure pin is securely seated into bone.

Helpful Hint

Using the shortest pin possible is preferable for stability and reachability.

Affix the Bridge Adaptor to the Surgical Arm

Align the sterile Bridge Adaptor to the Front Plate of the draped Surgical Arm. While holding the
Bridge Adaptor in position, use the StarDriver to gently turn the two screws clockwise until the part is
firmly secured

Warning

When affixing the Bridge Adaptor, the screws will puncture the Sterile Sleeve, therefore the Bridge
Adaptor should not be removed from the Surgical Arm prior to the completion of the Mazor X
Procedure

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Attach the Schanz Bridge onto the Surgical Arm

Slide the Bridge Lock onto the Schanz Bridge, positioning it close to the large ball joint. Hold the
Schanz Bridge with its large ball joint and Bridge Lock unit facing the Bridge Adaptor.

Warning

The bottom of the Bridge Lock must be seated on top of the lip at the base of the Bridge Adaptor.

Note

Make sure to align the Bridge Lock screw and locating pins with the designated screw hole
and grooves, respectively.

Note

Before tightening the Bridge Lock screw, the surgeon should adjust the Schanz Bridge to the required
angle (corresponding with the patient's anatomy) to allow easy attachment to the selected Bone
Mount.

Finger-tighten the Bridge Lock screw.

Affix the Schanz Bridge to the Schanz Screw

Position the hole at the base of the Schanz Connector over the top (distal end) of the Schanz Screw
then slide the Connector down, locking it into position by tightening the socket screw. Apply counter
torque to the Schanz Connector while tightening.

Helpful Hint

Before performing the next step, make sure that the Schanz Connector socket screw is completely
open prior to the insertion of the Schanz Bridge small ball joint into the socket.

Then move the Surgical Arm (with Schanz Bridge attached) towards the Schanz Connector, aligning
the small ball joint of Schanz Bridge with the socket on the side of the Schanz Connector. After
insertion of the ball joint into the socket, lock the Schanz Bridge into the Schanz Connector by
tightening the socket screw at the top of the Connector. Apply counter torque to the Schanz
Connector while tightening.

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Note

Keep approximately 3cm between the base of the Shoulder and the skin surface when possible (as
shown).

Helpful Hint

For optimal Surgical Arm reachability, align the Front Plate to the center of the spine. Orientation of
the Schanz Bridge should look like a Z from the top view.

Finally, tighten the Bridge Lock using the Star Driver. The Schanz Bridge is now securely affixed to the
Surgical Arm.

After locking, verify the platform stability. Once the arm is attached to the patient, avoid any patient
movement.

Note

The below pop-up message will be displayed any time a Stealth-Midas™ System, 1/4" Posterior
Osteotome, and/or 1/2" Posterior Osteotome is added to a CT-to-Fluoro procedure OR when CT-to­Fluoro registration is chosen AND one of the above-mentioned instruments is already in the
procedure.

3Define Scan

Perform a 3Define Scan

Prior to performing a 3Define Scan, place a green or blue sterile towel over the site if there is blood or
reflective metal in the area being scanned. If a reference frame is being used on the patient, cover that

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with the blue sterile towel as well. The towel should be tight around the anatomy coupler and patient
reference frame. The towels and drapes may be removed following the scan.

Navigation Registration

Navigation Registration creates a three-dimensional map between the points on the Reference Frame
and the robotic system via the Snapshot Tracker.

The Snapshot step is how the system achieves navigation registration. Taking a snapshot consists of
positioning the navigation camera where it can visualize the Snapshot Tracker attached to the robotic
surgical arm as well as the Reference Frame. The Snapshot process saves these relative positions and
relates them to the position of the robotic system. This allows the navigation to display instruments in
relation to the 3-D map of the Robotic System.

Click Snapshot Position button to send the arm to the default position. Once the arm has reached the
Snapshot position, attach the Snapshot Tracker to the arm guide with the corresponding target screw.
Then press the “Acquire” camera icon button.

Important

In some cases where the patient volume is large, the system may not be able to send to a position
close enough for an accurate snapshot. If this occurs, it will send to a location and will have a banner
message alerting the user to press the down arrow to manually move the arm closer to the patient,
while ensuring they do not collide with the patient, screw extenders, or other instrumentation.

Important

The intraoperative workflow begins after the Surgical Arm has been affixed securely to the patient’s
bony anatomy.

Registration

CT-to-Fluoro Registration Steps

Note

The steps in this section are the standard workflow utilizing CT-to-Fluoro registration. For instructions
specific to the Scan and Plan registration workflow, refer to Appendix C.

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Robotic Registration

Robotic Registration creates a three-dimensional map between the robotic system and the patient
anatomy as it is positioned on the OR table. This is accomplished by imaging the bony anatomy with a
radiopaque marker (3-D Marker or StarMarker) at the end of the robotic arm at a precise location). The
radiographic 2-D images or 3-D image is used by the Mazor™ Robotic Guidance Platform Software to
register the coordinates of the patient anatomy with the 3-D map of the Robotic System.

Draw the Required Spine Segment

Ensure that the instruments have been verified and the snapshot step is complete before attempting
the Draw Spine step. The draw spine feature locates the operative levels of the spine. Based on
rotation, kyphosis, or lordosis of the target segment from the CT, the surgical arm will position itself to
take optimized images.

Position the passive planar probe above the patient with the tip at the cephalad point of the spine
segment operative level. If operating on two segments, choose only the segment currently being
operated on and not the entire spine. Tap the “Set Head pt” button. Move the passive planar probe
and place the tip at the caudal point of the spine segment operative level. Tap the “Set Feet pt” button.
The Mazor X™ software will identify the defined area for placement of the 3-D Marker. On the screen,
a green line is displayed over the spine segment. Open the labeling drop-down menu, then choose
the appropriate vertebral label corresponding to the center of the defined area.. For detailed
instructions, refer to the Mazor X Stealth Edition™ User Manual.

CT-to-Fluoro Registration

Send the arm to the AP position and assemble the 3-D Marker to the end of the target extender. Attach
the target extender and 3-D Marker assembly to the arm guide and use the arm guide screw to secure.

Take an AP image with optimal clarity of the anatomical region of interest and all of the beads on the 3­D Marker. Remove the target extender and send the arm to oblique position. Reattach the target
extender and take an image of the oblique view, looking for the same characteristics. Use these two

images to register in the Mazor™ Robotic Guidance Platform Software. Refer to the Mazor X Stealth
Edition™ User Manual for detailed information.

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Accuracy Check

The robotic registration registers the surgical arm to the patient, while the navigation registration
registers the navigation reference frame to the surgical arm. After both registrations are complete, the
system can display the location of navigated tools relative to patient anatomy.

Instrument skiving or inaccurate navigation registration can be visible through the misalignment
between the navigated instrument and the planned trajectory in the software. Inaccurate navigation
registration can be ruled out by following the accuracy check instructions below.

Important

Accuracy check before sending the arm to the first trajectory:

Touch a navigated instrument to the Snapshot checkpoint on the side of the Arm Guide. The accuracy
check view will open after two seconds or the operator may manually select this view.

If the image displayed shows the instrument inside the checkpoint divot, proceed to the patient
accuracy check. If the image displayed shows the instrument outside of the checkpoint divot, repeat
the Snapshot Registration process and then repeat the two-step accuracy check.

Accuracy check during the case, using a patient reference frame:

Touch a navigated instrument to the Snapshot checkpoint on the side of the Arm Guide. If the image
displayed shows the instrument inside the checkpoint divot, proceed to the Patient Accuracy Check:

• Touch a navigated instrument to known patient anatomy.

• If the image displayed is an accurate navigation representation, both registrations are still

valid.

• If the image displayed is an inaccurate navigation representation, re-register with CT-to-Fluoro.

If the image displayed shows the instrument outside the checkpoint divot, proceed to the patient
accuracy check:

Touch a navigated instrument to known patient anatomy.

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• If the image is an inaccurate navigation representation, either reference frame has moved or

patient motion relative to the robotic system has likely occurred. Send the arm to the snapshot
position, take a new snapshot. Verify that the snapshot acquisition is successful by touching the
snapshot checkpoint. Then, verify patient accuracy by touching an anatomical landmark. If it is
accurate you can proceed, and both registrations are now valid. If the image is still not
accurate, a new CT-to-Fluoro registration is necessary.

• If the image is an accurate navigation representation, navigation is still valid, but patient had

likely moved, and the robotic registration is no longer valid. Therefore, you can use freehand
navigation tools, but you should not use robotic guidance without completing a new CT-to­Fluoro Registration.

Important

Always perform both the Snapshot Check and the Patient Accuracy Check. Performing a new Snapshot
Registration alone will not enable the user to visualize if the patient has moved relative to the robotic
registration.

Note

Saved projection items are available for the current registration only. Re-registration will automatically
delete any saved items.

Pedicle Access Preparation

Send Arm to First Trajectory

Before making the incision, the surgeon may confirm the trajectory by placing the navigated Dilator
and Cannula assembly through the arm guide.

Ensure the correct level and side is selected and press “Send Surgical Arm.”

Helpful Hint

Ensure instruments are set up correctly with corresponding NavLock™ Tracker and instrument tips in
the Instruments Tab of the software.

Important

The planned screw will appear on the end of the driver CAD file. To change the planned screw, select
“Planning” and revise the screw dimensions. Select "Operation" to return to the screen and send the
arm again if you modified the plan. The surgical arm can also be moved by selecting a specific pedicle
and selecting “Send”.

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Incision

Make an incision, as follows:

1. Assemble a blade size #22 or #24 (#4 connection type) onto the scalpel handle.

2. Insert the scalpel handle through the Arm Guide and puncture the skin. Remove from skin,

rotate 180 degrees and puncture skin again.

3. Enlarge the skin incision using a scalpel if necessary.

4. Continue the incision through the dorsal fascia. Push - do not rotate - the scalpel.

5. Remove the scalpel holder.

Important

Making the incision with the scalpel blade should not require significant force. Replace a dull blade
prior to making the stab incision.

Note

External surfaces of instruments should be inspected and wiped between each instrument insertion
through the arm guide and/or through the cannula to reduce the probability of binding.

Cannula Insertion

Insert the navigated Dilator into the Cannula. Insert the Cannula/ Dilator assembly into the Arm Guide.
Incrementally push and rotate the Cannula/ Dilator assembly toward the pedicle surface utilizing
navigation visualization to avoid contacting adjacent bony anatomy. This method clears a path through
the muscles for the Cannula. Using navigation to monitor depth, continue to push and rotate until the
Dilator lightly contacts the pedicle surface. Continue advancing the Cannula until the laser-marked line
on the Dilator is just visible. This positions the distal end of the Cannula approximately 10mm above
the bone surface. Remove the Dilator, leaving the Cannula in position for the duration of pilot hole
drilling and tapping steps.

Note

CD Horizon™ Ballast™ cannula, dilator, drill guide, drill, and taps should be used for screw lengths
greater than 60mm and/or diameters greater than 7.5mm.

Important

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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.

Important

When using a navigated instrument, it is recommended to periodically check accuracy. See Accuracy
Check instructions on page 18 for details.

Important

Do not retract the tapered Cannula such that the laser-marked 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 and Tapping

Drilling

Note

To ensure accuracy of robotic guidance, all pedicle drilling and tapping steps that require robotic
guidance must be completed prior to any disc work. Robotic guidance should be not used if any
anatomy has shifted after the robotic registration is performed.

Note

See Midas Rex™ Drill System IFUs for instructions on how to assemble, operate, disassemble, clean,
and sterilize the Midas Rex™ Drill System.*

Alternatively, the IPC™ Powerease™ System and AO-style** drills with compatible drill motors can also
be used to drill pilot holes and are the only options to create 4.2mm diameter holes up to 70mm deep.
See Appendix B for instructions on using the IPC™ Powerease™ System for drilling pilot holes.

Important

Midas Rex™ dissecting tools are indicated for single use only.

Important

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The pedicle must be cannulated by drilling a pilot hole prior to performing any of the subsequent steps to
reduce the probability of skiving.

Choose the appropriate Midas Rex™ attachment and dissecting tool per the table below.

Assemble the attachment and dissecting tool onto the motor as described in Midas Rex™ Drill System
IFU documents. Lightly place the Midas Rex™ drill system into the cannula such that the Midas
dissecting tool is resting on the bone. If using navigation, verify the trajectory on the screen. Once
confirmed, lift the Midas Rex™ drill system slightly off the bone, power the motor, and guide the
dissecting tool into the pedicle with light forward motion to the appropriate depth. While still powered
until the dissecting tool is completely removed from the anatomy, remove the Midas Rex™ Drill
System.

Important

Drill the pilot hole to pass the posterior cortical wall of the vertebral body at minimum without
breaching bone. Shallow depth pilot holes may result in screw deviation and/or robotic arm damage
during tapping and screw insertion steps. In-Out- In trajectories are an exception to this guidance.

Important

To avoid potential navigation inaccuracy, exercise caution while drilling to limit the application of
excessive force that could bend the Midas Rex™ dissecting tool and displace the anatomy. This only
pertains to the navigated configuration of the Midas Rex™ Drill System.

Important

Ensure that the nomenclature and color code on the Midas Rex™ attachment and dissecting tool
packaging match. The Midas Rex™ attachment and dissecting tool length must match the indicated
solution (short or long) within the Mazor™ Robotic Guidance Platform. Failure to match the Midas
Rex™ attachments and dissecting tools properly can cause inaccuracy and/or patient injury.

Important

The 23cm and 31cm Midas Rex™ Drill System should always be used within a cannula.

23

*Midas Rex™ Drill System Instructions for Use

Midas Rex™ Legend™ and MR8™ System - 23cm and 31cm Attachments and Tools
Midas Rex™ Legend™ and MR8™ - Navigated 23cm and 31cm Attachments and Tools

**AO is a trademark of AO Technology.

Pilot Hole Depth Control

The distal end of the Midas Rex™ attachment acts as a positive stop against the pedicle surface and
limits the pilot hole depth to 30 mm. The maximum pilot hole depth will be less than 30 mm when
drilling on angled surfaces.

Laser markings on the attachment tube are provided in 10mm increments up to 30mm to indicate
drilling depth. Additionally, navigation can also be used to indicate drilling depth (applicable to
navigated configuration of Midas Rex™ drill system only).

Important

When confirming navigation accuracy, release force on instrumentation to minimize risk of anatomy
shift or instrument flexing.

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.
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.

Note

When using the NavLock™ Tracker attached to instruments, care must be taken to avoid colliding the
NavLock™ Tracker with the robotic arm. When a collision is predicted by the system, it will alarm and

the arm will flash red to alert the user.

24

Important

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.

Important

It is recommended that intraoperative navigation guidance be used to aid screw placement. Awl-Tap
Screws should not be used for bicortical fixation.

Important

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.

Helpful Hint

If the surgeon prefers a fixed position for the Navlock™ Tracker when using the Powerease System, the
NAV Powerease Adapter (9734335) can be used. This adapter holds the NavLock™ Tracker in a fixed
position in relation to the Powerease handpiece and can be helpful to maintain alignment of the
tracking spheres with the navigation camera.

*Multi-Axial Awl-Tap Screw (ATS™)

The ATS bone screw design has a tapered awl tip with cutting flutes which obviates the tapping steps prior to screw placement.
Due to the sharp tip design, use of intraoperative guidance is recommended. The implant can be used with the navigation
enabled Mazor™ Robotic Guidance Platform and navigation compatible IPC™ Powerease™ System.

Screw Insertion

The screw attached to the driver must be the same size, both in length and diameter, as well as screw
type to the planned screw in the in the Mazor™ software for navigation to be accurate.

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 that the tab extenders of the CD Horizon™ Solera™ Voyager™ System slide into
the retention features on the driver so the extenders are contained during screw insertion.

Remove the Cannula.

25

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 screw head is placed against the bone, it will lose its multi-axial capabilities and make it
difficult to connect the screw assemblies during subsequent steps. Remove the driver from the 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 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.

The software will use the Tower Collision Detection feature to move the arm guide up and over the
tower before moving to the next trajectory. The software will also consider the location of the towers in
the working volume throughout the procedure. Refer to the CD Horizon™ Solera™ Voyager™ Surgical
Technique for surgical steps following screw placement.

Helpful Hint

The StarDriver can be inserted into the holes of the driver to help disengage the screw from the driver
if additional leverage if needed.

Helpful Hint

For in-out-in trajectories, consider using a guidewire-based workflow (see Appendix B). Cannulated
instruments from the standard Solera™ instrument sets must be used.

For detailed instructions on the screw system, please refer to the CD Horizon™ Solera™ Voyager™
Surgical Technique or the CD Horizon™ Solera™ Voyager™ 5.5/6.0mm Surgical Technique.

Important

Add caps onto extenders after screws are placed, prior to rod insertion.

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Transition from Robotic Guidance Navigation to
Freehand Navigation

Clear the surgical arm to the right or left prior to proceeding to the interbody navigation steps listed in
the next section of this technique.

Navigation has been disabled for posterior bony decompression instruments when using CT-to-Fluoro
registration because there may be diminished navigation accuracy for some posterior bony anatomy.
This includes the Stealth-Midas™ Legend and MR8, the 1/4" Posterior Osteotome, and the 1/2"
Posterior Osteotome. To enable these instruments, please perform a Scan and Plan registration.

This warning will be shown if user attempts to use robotics after the system has detected a navigated
disc prep/interbody instrument near the disc space.

Helpful Hint

If the surgeon intends to utilize any planned robotic trajectories to mark skin incisions for interbody
access, these must be executed prior to disconnecting the bone mount from the patient.

Disconnecting Bone Mount

After robotic guidance of screw preparation and insertion is complete and prior to moving on to
navigated interbody steps, it is recommended to perform the Accuracy Check to ensure navigation is
still accurate and the patient reference frame hasn’t experienced motion. See Accuracy Check
instructions on page 17. Without unlocking the robotic arm shoulder, clear the robotic arm away from
the operative field to any pre-defined trajectory. Using the Star Driver loosen the screw on the Schanz
Connector that secures the Schanz Bridge, then loosen the Bridge Lock with the Star Driver. Rotate the
Schanz Bridge and Bridge lock assembly away from the Bridge Adaptor and the distal end out of the
Schanz connector. Optional to remove the Schanz connector from Schanz pin.

27

Important

After disconnecting the robotic system from the patient, the access, retraction, navigated
decompression, and interbody insertion steps may proceed.

Important

Do not re-snapshot after the patient has been disconnected from the Bone Mount (during lateral
interbody navigation steps).

The accuracy check in this scenario will be modified: navigation accuracy should only be checked on
known patient anatomy. If the user attempts to select Snapshot after they have started utilizing
interbody navigation capabilities, a warning will pop up advising against taking a new snapshot.

DLIF Interbody Procedure

Interbody Options

The DLIF Procedure requires the use of an interbody fusion device. Medtronic offers a number of
interbody fusion devices to support DLIF procedures, including the Anteralign™ TL System, which can
be navigated. Refer to the appropriate interbody fusion device surgical technique for trialing and
implantation instructions.

Precise placement of the bone graft (Grafton DBF, Allograft, or Autograft) is essential to facilitate
fusion. For details on Grafton™ DBF Inject Bone Graft use with Anteralign™ TL, refer to the
Anteralign™ TL surgical technique.

Important

Special considerations need to be made for any step of the procedure that could alter the anatomy,
such as placement of the interbody implant, as this may change the height of the intervertebral disc
space.

Important

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The disc removal and interbody placement steps are to be completed by the surgeon’s normal
procedure as these steps are not completed with the robotic guidance. Navigation guidance may be
used.

Neuromonitoring (Required)

The Direct Lateral Dilator described in this technique is compatible with neuromonitoring. Electrode

placement should be performed using the surgeon’s standard electrode placement technique. After

the patient is asleep, needle recording electrodes are placed in the innervated muscles in the legs to
monitor the affected nerve roots during the procedure. Please follow the instructions below, as well as
the accompanying electrode placement guide, to correctly place the electrodes in the appropriate
muscles for the desired levels.

1. Electrodes are placed prior to patient draping and the establishment of the sterile field.

2. Clean the areas with alcohol wipes.

3. The green lead ground electrode should be placed between the stimulator and the

monitoring electrodes in a location where the bone is close to the skin and the electrode will
not contact muscle.

4. The white stimulus return electrode should be placed near the location of stimulation. Connect

the Probe lead wire to the instrument jack of the patient interface module.

5. Tape all of the electrodes securely in place and plug the leads into the patient interface box

and turn on the NIM-Eclipse™ Spinal System* to begin monitoring.

Helpful Hint

Let the anesthesiologist know EMG monitoring will be used during the procedure to ensure that no
neuromuscular blocking agents are administered during monitoring. During intubation, a fast-acting
neuromuscular blocking agent should be used.

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Localization

Use the narrow Passive Planar Ball-tipped Probe and aim for the center of the disc space at the level of
interest and mark the skin. A projection can be helpful to locate the trajectory to the disc space. Under
“Select Projection" on the workstation, add a tip extension to the tip of the instrument. The projection
may be lengthened as needed to accommodate patient size.

DLIF Site Access

After the proper position has been established and the incision has been made, the subcutaneous fat
layers are dissected until the abdominal musculature is reached. The external oblique fascia will be the
first plane encountered and is the only layer that will need to be sharply incised. A Kelly Clamp may be
used to bluntly spread through the fibers of the external oblique, internal oblique, and transversalis
abdominis muscles. All dissection is done in line with the muscle fibers. Once inside the
retroperitoneal space, the index finger is used to follow the internal abdominal wall posteriorly down

30

to the psoas muscle, which can be visualized. Use of the finger to sweep the peritoneal contents as
well as the retroperitoneal fat anteriorly will allow a clear path down to the psoas muscle.

After a safe retroperitoneal pathway to the psoas has been established, the first Direct Lateral

Dilator/MAST™ Dilator Tracker is guided down to the psoas while using the finger to protect the

peritoneal membrane. The entry point of the Direct Lateral Dilator/MAST™ Dilator Tracker into the
psoas should be targeted between the anterior half to third of the disc space in order to avoid the
nerves of the lumbar plexus and to remain posterior to vascular structures. It is important to maintain
the proper trajectory during dilation. On the Mazor X™ Guidance System, a cylindrical projection may
be added to the Direct Lateral Dilator to get an approximation of where the Retractor will be
positioned on the lateral spine.

After the proper position has been established, carefully pass the Direct Lateral Dilator/MAST™ Dilator
Tracker through the psoas muscle. If desired, the NIM-Eclipse™ E4 System screen can be imported as
one of the views on the workstation monitor.

At this point, it is recommended to perform the two-step accuracy check. See accuracy check
instructions on page 17.

Helpful Hint

At any point during the procedure, navigation accuracy can be evaluated by using the first Direct
Lateral Dilator/MAST™ Dilator Tracker on known bony landmarks.

Important
Please see the NIM-Eclipse™ Spinal System package insert and user’s manual for complete
instructions and a list of warnings, precautions, and other medical information. The NIM-Eclipse™
Spinal System is intended for use to record, monitor, and stimulate/record biopotential signals
including electromyograph (EMG), evoked response and nerve/muscle potentials, and intraoperative
diagnosis of acute dysfunction in corticospinal axonal conduction. The system provides feedback to
the surgeon and OR team to assist in the localization and assessment of spinal nerves and verification
of placement of spinal instrumentation to avoid injury to at-risk nerve roots.

Remove the MAST™ Dilator Tracker and sequentially insert the dilators until the desired diameter is
reached.

Measure the depth from the skin to the disc space using the graduated markings on the dilators and

select the appropriate retractor blades. Attach the blades to the Lateral Retractor base and place the

31

assembly over the grooved Dilator. It is important to align the retractor blades so that the opening

between them is parallel to the disc space. The retractor assembly is then attached to the Flexible Arm

using the Rotating Flex Arm Attachment to provisionally maintain retractor position. Use the NIM™

Spine Ball-tip Probe to test both Stability Pin channels of the Retractor Blades to ensure a nerve-free

pathway before placing a Stability Pin. To help prevent retractor migration during the procedure,

insert the Stability Pin through the Retractor Blade that is closest to the endplate. With the Stability Pin

in place, the Dilator Tubes are removed, leaving only the Retractor Assembly. For multi-level cases, it is

recommended to begin the procedure at the level farthest from the reference frame, and then work

closer to the frame to help maintain accuracy.

Note

For additional information on the retractor assembly and options, refer to the OLIF25™ Surgical

Technique.

Disc Preparation

The Straight Tip Radiance Illumination System is attached to the Retractor Blades by placing the tips of
the light source into the holes on the top of the blades and then sliding the tips under the built-in
retaining sleeves. A Penfield 4 can be used to sweep the residual muscle off of the disc space until the
annulus is visualized. The annulus is then incised and an annulotomy (at least 18mm in length) can be
created using the Bayoneted Knife.

On the workstation, ensure to select the appropriate navigated instrument tip. Insert the navigated
instruments into the appropriate NavLock™ Tracker and confirm accuracy by touching the tip of the
instrument on a known anatomical point. The discs can now be removed using Navigated
Anterolateral Disc Preparation Instruments, Navigated Lateral Disc Preparation instruments, and
general instruments until the desired discectomy is achieved.

The surgeon can perform a thorough discectomy in the usual fashion. Kerrisons and Pituitaries are
used to perform thorough discectomies. A Large Cobb can be passed along both endplates to release
the contralateral annulus. Cobbs can be used to pry disc away from bony endplates. Curettes can be
used to remove disc and prepare endplates. Rasps and Shavers can be used to prepare endplates.
Distractors can be used to open disc space prior to trialing. The osteotome can be used to remove

32

osteophytes and other bony protrusions. General instruments for discectomy and endplate
preparation can be used per the surgeon's preference.

Important

Make sure the navigated disc prep instruments were verified with a default tip such as an awl or tap.
Use the Tip Dropdown Menu when choosing the applicable tip for the disc prep working end.

Important

The Quick-Connect Handle is compatible with the navigated curettes and rasp instruments only. No
impaction forces, such as malleting, should be applied to the Quick-Connect Handle as this will
damage the instrument and will prevent the removal of the NavLock™ from the instrument.

Trial Insertion

The disc space is sequentially distracted with Trials until adequate disc space height is obtained and
adequate foraminal size is restored by selecting appropriate Trial width, length, and lordosis angle.

Anteralign ™ TL Spinal System Trials are available in 8mm, 10mm, 12mm, 14mm and 16mm heights.

All Anteralign ™ TL trials have a length of 60mm, while the software can provide a visual indicator for
lengths of 40mm, 45mm, 50mm, 55mm, and 60mm. If other size options are desired, follow the
Synergy DLIF™ and SynergyOLIF25™ Surgical Techniques using non-navigated instruments for the
trialing step.

The trials are passed through the retractors direct laterally. On the Mazor™ System, select the

appropriately sized Trial. Insert the Anteralign Trial with a Nav Lock™ Tracker into the disc space until

the desired height is established by way of proper placement and alignment of the trial. Confirm
proper placement and alignment of the Trial. Remove the Nav Lock™ Tracker and then use a Slap
Hammer from the trial set if needed to remove the Trial.

Helpful Hint

Keep in mind that when moving bony anatomy, it will not be detected on the Mazor™ Workstation.
During navigation, it is important to frequently confirm navigational accuracy by touching the tip of the
navigated disc prep instrument on known anatomical points, including accuracy checkpoints, and
comparing the position to the instrument tip in the image with its physical location. If needed, re­registration will be performed before continuation of the procedure.

33

Helpful Hint

At any point during the procedure, navigation accuracy can be evaluated by using the first Direct
Lateral Dilator/MAST Dilator Tracker on known bony landmarks.

Helpful Hint

Please note that the Anteralign Inserter is not symmetric and the projection tool references the center
point of the trial/ implant. This will appear offset if the user saves any projections from a symmetric disc
prep tool.

Interbody Placement/Closure

Before inserting the Anteralign™ TL Spinal System implant, place Grafton™ DBF Inject Bone Graft,
autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft in

the implant’s central cavity. Attach the Anteralign™ TL Spinal System implant to the Navigated Inserter.
On the Mazor™ System, select the appropriately sized implant. Use a mallet to gently insert the

implant. The Navigated Inserter is then unthreaded from the implant and removed.

After implant has been inserted into the disc space, the Stability Pin may be unthreaded and removed.
The Retractor is then detached from the Flex Arm and the Retractor Blades are carefully withdrawn
from the surgical site. As the Retractor is removed, the muscle and fat layers can be visualized closing
back into place.

The surgical site is irrigated appropriately and the fascia over the external oblique is then closed with
interrupted synthetic absorbable suture.

Finally, the subcutaneous layers and skin are closed and the skin is sealed with skin adhesive.

Rod/Set Screw Insertion

For detailed instructions on the screw system, please refer to the CD Horizon™ Solera™ Voyager™

5.5/6.0mm Surgical Technique.

34

Confirmation Image Acquisition (Optional)

With the patient isocenter, position the O-arm™ System to perform a 3-D image acquisition. During
the acquisition process all personnel who are not wearing protective lead apparel should stand at least
15 feet from the O-arm™ System with a certified moveable lead shield between themselves and the O­arm™ System to avoid unnecessary radiation exposure. Perform the image acquisition to confirm
screws, rods, and interbody placement.

Removing the Surgical System

The Mazor™ Robotic Guidance Platform may be removed once navigation steps are complete as long
as it doesn’t interfere with remaining surgical steps. The removal procedure is described in the
Mazor™ Robotic Guidance Surgical Technique Guide.

Implant Explantation

CD Horizon™ Solera™ Voyager™ 4.75mm System

The CD Horizon™ Solera™ Voyager™ 4.75mm Cannulated Multi-Axial Screws, Multi-Axial Awl-Tap

Screws, Set Screws and Rods may be removed by applying a Ball-Ended Driver, or Removal Driver to

the Set Screw and turning counterclockwise until the Set Screw is removed. CD Horizon™ Solera™
Voyager™ 4.75mm Cannulated Multi-Axial Extended Tab Screws and Extended Tab ATS Multi-Axial

Screws may be removed by applying the Multi-Axial Screwdriver, Ball-Ended Driver, or Removal Driver
from the CD Horizon™ Solera™ Voyager™ 4.75mm Instrument Set to the Screw and turning
counterclockwise until the Screw is removed from the pedicle.

CD Horizon™ Solera™ Voyager™ 5.5/6.0mm System

The CD Horizon™ Solera™ Voyager™ 5.5/6.0mm Cannulated Multi-Axial Screws, Multi-Axial Awl-Tap

Screws, Set Screws and Rods may be removed by applying a Ball-Ended Driver, or Removal Driver to

the Set Screw and turning counterclockwise until the Set Screw is removed. CD Horizon™ Solera™
Voyager™ 5.5/6.0mm Cannulated Multi-Axial Extended Tab Screws and Extended Tab ATS Multi-Axial

Screws may be removed by applying the Multi-Axial Screwdriver, Ball-Ended Driver, or Removal Driver

from the CD Horizon™ Solera™ Voyager™ 5.5/6.0mm Instrument Set to the Screw and turning

counterclockwise until the Screw is removed from the pedicle.

35

Appendix A: PSIS Reference Frame Option

When performing a Prone Lateral Single-Position procedure use of the Spinous Process Clamp with
the Small Passive Reference Frame is recommended.

Alternatively, the Percutaneous Reference Pin with the Percutaneous Reference Frame can be used.
Pins are available in 100mm and 150mm lengths.

The preferred method places the pin down the posterior superior iliac spine (PSIS) much like the
trajectory of an iliac screw, which drops the reference frame out of the way and does not pose
potential line-of-sight obstacles between the camera and the screw placement. This option is
described below.

Using palpation, locate the PSIS on the patient. Mark the skin a little medial and inferior to the PSIS to
verify the appropriate location to place the pin.

Make a stab incision and locate the Cannula with the Dilator over the PSIS. Place the Dilator/Cannula
into the incision through the tissue until it contacts bone.

Once docked, the Dilator/Cannula assembly is tapped with a mallet to make an indentation in the
bone for the pin. While holding the Cannula in place remove the Dilator and insert the pin through the
Cannula. Place the Tap Cap on the pin and rotate the cap so the arrow on the Tap Cap points toward
the camera.

Orient the Pin/Tap Cap assembly to ensure:

a) the reference frame can be seen by the camera
b) the reference frame is not obstructed by the patient’s own anatomy
c) the reference frame is not at risk of being obstructed by a hand during procedure
d) the reference frame is not at risk of contact or deflection by the trajectory of a navigated

instrument

e) the percutaneous pin is not pushing against the skin

Use an impactor to drive the pin into the bone until the Tap Cap contacts the top of the Cannula.
Remove the Tap Cap from the pin and attach the Percutaneous Reference Frame to the pin.

36

Important

Ensure the Reference Frame is properly secured to anatomy. Make certain there is minimal skin and
soft tissue tenting, as this may lead to drift motion of the pin. Neglecting to verify that the Reference
Frame is secured could result in navigational inaccuracy if the hardware moves in relation to the
anatomy after registration is complete.

Appendix B: Hybrid Guidewire Option

Guidewires can be inserted into the desired trajectories in the same surgical case where implants at
other levels are inserted using a guidewire-less procedure. This can be accomplished by drilling the
trajectory with a Midas Rex™ or IPC™ Powerease™ System.

Option 1 - Drill Pilot Hole with Midas Rex™ System

Choose the appropriate Midas Rex™ attachment and tool. Assemble the attachment and tool onto the

motor and place the drill assembly through the cannula. Place the drill assembly on the pedicle to
confirm orientation (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. Insert the Mazor drill guide into the
cannula such that the drill guide touches the bone surface. Do not mallet the drill guide into bone.

Option 2 - Drill Pilot Hole with IPC™Powerease™ System

Insert the appropriate drill bit into the IPC™ Powerease™ driver. Without drilling, insert the drill bit
into the Drill Guide until it contacts bone. Ensure smooth passage of the drill bit within the Drill Guide.
While holding the drill bit with one hand, tightly hold the top of the Drill Guide with the other, then
accelerate rotation of the drill bit to the highest possible revolutions-per-second, pressing the drill bit
into the bone with medium force. Remove the drill but leave the drill guide in place.

Guidewire Insertion and Removal

Insert the MAS0542 SA Reduction Tube through the Drill Guide and into the pilot hole. Insert the
guidewire into the Reduction Tube. Gently tap the guidewire so that it sets into the bone. Remove the
Reduction Tube, Drill Guide, and Cannula. Gently remove the guidewire from the Arm Guide by
pulling it through the slot in the Arm Guide.

37

Appendix C: Scan and Plan Workflow

Image Acquisition

At any time when fluoroscopy is used (2-D or 3-D acquisition) all personnel who are not wearing
protective lead apparel should stand at least 15 feet from the O-arm™ System with a certified
moveable lead shield between themselves and the O-arm™ System to avoid unnecessary radiation
exposure.

Send the Arm to Either “AP” or to “Follow Me”. When sending Arm to “AP”, press “AP”, confirm the
area is clear and then press “Send Arm”. When sending to “Follow Me”, hold the Passive Planar Probe
over the center of the spinal anatomy being instrumented and press the “MARKER” button. Next,
remove the Passive Planar Probe from the patient’s back and press “Send Arm.”

Important

When moving the O-arm™ System into place for registration, take care to not bump the StarMarker,
Robotic Arm, or Shoulder. Mount the StarMarker on top of the Target Extender and screw it in position
with the StarMarker Screw. Ensure that the StarMarker is flush with the Target Extender. Take care to
not over-tightened the screw.

Important

Proper orientation of the StarMarker and Target Extender is critical. Insert the other end of the Target
Extender into the Arm Guide, as follows:

1. Slide the Target Extender over the base of the Arm Guide, taking care to align the notch at the

end of the Target Extender with the locating pin on the Arm Guide.

2. Slide the arm guide screw into the top of the Arm Guide and screw it in all the way.

3. Make sure the Target Extender is properly mounted onto the Surgical Arm, with surfaces flush

against each other, then finger-tighten the arm guide screw to lock it firmly in position.
Establish the surgery site using 2-D fluoroscopy scout images as needed.

Important

The Field-of-View (FOV) should include the StarMarker (four beads) and the anatomy being
instrumented.

38

Helpful Hint

Take care to avoid positioning the StarMarker beads near other metal instruments (mounts or
reference frames) in order to avoid potential artifact distorting the beads.

Image Acquisition

To help avoid artifact the following methods may be helpful:

• Position StarMarker as close to the body as possible without touching the patient.

• Attempt to minimize air in image as best as possible. On the control panel, select the patient

size, anatomy, and orientation. With the patient isocenter, position the O-arm™ System gantry
to perform a 3-D spin. Refer to the O-arm™ System User Manual for additional information.
Upon completion of the intraoperative 3-D Scan, a message is displayed confirming that the
StarMarker was recognized. If the StarMarker was not recognized, improve the
positioning/FOV selection and perform an additional scan.

Helpful Hint

If needed, depending on patient size, utilizing the 40cm Field of View (available on the O-arm™ O2
System) may help to fit all four beads in the work volume.

Helpful Hint

Image quality may be improved by using the High Definition (HD) mode and reducing the patient size
by one (i.e. M to S) to reduce mA. This can also be achieved by leaving patient size as is but manually
reducing mA one to two steps.

Helpful Hint

Keep the Surgical Arm in the same position until the scan has been successfully transferred.

Image Transfer

Import the intraoperative 3-D device scan using direct (LAN cable) or (USB) storage device. Once the
images are transferred and the four beads have been located by the Mazor™ System software, the O­arm™ System can be moved out of the way and into the park position. The Surgical Arm should
remain in the same position until the scan has been successfully transferred.