Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AN 82-YEAR-OLD FEMALE UNDERWENT PLANNED THORACIC PERCUTANEOUS INSTRUMENTATION FOR AN UNSTABLE T5 FRACTURE USING ROBOTIC NAVIGATION. DURING THE PROCEDURE, ROBOTIC REGISTRATION WAS PROLONGED AND TECHNICALLY CHALLENGING. DURING PEDICLE SCREW PLACEMENT, LOSS OF RESISTANCE WITH CSF RETURN WAS NOTED AND INSTRUMENTATION WAS STOPPED. SHORTLY THEREAFTER, NEUROMONITORING SIGNALS WERE LOST, AND THE PATIENT EXPERIENCED A PULSELESS ELECTRICAL ACTIVITY (PEA) ARREST WITH RAPID RETURN OF SPONTANEOUS CIRCULATION FOLLOWING BRIEF RESUSCITATION. POST-EVENT EVALUATION DEMONSTRATED ACUTE MYOCARDIAL DYSFUNCTION WITH PATENT CORONARY ARTERIES AND IMAGING FINDINGS CONCERNING FOR THORACIC SPINAL CORD INJURY RELATED TO A MEDIAL PEDICLE BREACH. THE FOLLOWING DAY, THE SERVICE RECEIVED AN URGENT MANUFACTURER SAFETY NOTICE REGARDING ROBOTIC NAVIGATION SOFTWARE ACCURACY.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ON (B)(6) 2022 THE PATIENT HAD SPINAL SURGERY WITH USE OF MAZOR ROBOTIC ASSISTANCE. PER THE SURGEON, DURING THE PROCEDURE THE EXPANDING TECHNOLOGY FAILED. ALSO POST OP, IT WAS SUSPECTED THAT THE SCREWS PLACED BY THE MAZOR WERE MALPOSITIONED FROM THE PLANNED TRAJECTORY. ANOTHER PROCEDURE WAS REQUIRED FOR SCREW REVISION AND COMPRESSION OF THE EXPANDABLE CAGE. FDA SAFETY REPORT ID # (B)(4).

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: SPINAL FUSION COMPLETED USING MAZOR ROBOT. SCREWS WERE PLACED PER DIRECTION OF MAZOR ROBOT. AFTER SURGERY, PT FOUND TO HAVE MALPOSITIONED SCREWS RESULTING IN PT INJURY.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: WHILE USING THE MAZOR NAVIGATION / ROBOTIC SYSTEM LEFT SIDE SCREWS OF A SPINAL FUSION WERE IN PLACE. THE RIGHT SIDED SCREWS WERE MEDIAL DISPLACED AND REQUIRED RE POSITIONING. FDA SAFETY REPORT ID# (B)(4).

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION REGARDING A GUIDANCE SYSTEM BEING USED DURING A SPINAL PROCEDURE. IT WAS REPORTED THAT ALL OF THE SCREWS WERE NOT TO PLAN. ALL OF THE LEFT SIDE SCREWS WERE IN THE SPINAL CANAL AND THE RIGHT HAND SCREWS WERE LATERAL TO PLAN. PRIOR TO THE PROCEDURE, A 10 POINT ACCURACY CHECK WAS DONE AND THE GUIDANCE SYSTEM WAS ACCURATE ON ALL TRAJECTORIES. A SURGICAL ARM AND SHOULDER CHECK WERE ALSO DONE AND BOTH PASSED. THE TRAJECTORIES WERE PLANNED BY THE SURGEON AND THE C-ARM WAS CALIBRATED. THE GUIDANCE SYSTEM WAS PLACED ON THE BED AND DRAPED AS NORMAL. DURING THE PROCEDURE, EXPOSURE AND MARKING FILMS WERE DONE BEFORE THE SURGICAL SYSTEM WAS ATTACHED TO THE PATIENT. EXPOSE WAS GENEROUS AND THERE WERE NO ISSUE WITH SOFT TISSUE PRESSURE. A DUAL CLAMP WAS USED AT T4 AND T5. THE CONSTRUCT WAS RIGID BEFORE THE GUIDANCE SYSTEM WAS PLACED TO ATTACH TO THE CLAMP. A 3DEFINE SCAN AND DRAW SPINE WERE THEN COMPLETED. REGISTRATION WAS COMPLETED WITH TWO AP AND TWO OBLIQUE SHOTS. DURING IMAGING, RESPIRATION WAS SUSPENDED TO AVOID AN CROSS VIEW ERRORS. SEGMENTATION WAS ACHIEVED ON FIRST ATTEMPT AT LABELING AND ALL TRAJECTORIES WERE GREEN. REGISTRATION WAS APPROVED BY THE SURGEONS

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A GUIDANCE DEVICE BEING USED IN A SPINAL PROCEDURE. IT WAS REPORTED THAT THE STEALTH EDITION CAMERA UPGRADE WAS PERFORMED THIS PAST FRIDAY. THE 4.2 SOFTWARE HAD BEEN INSTALLED FOR A FEW MONTHS. STEALTH EDITION WAS NOT USED FOR THIS CASE. THE PATIENT WAS PLACED IN THE LATERAL POSITION FOR LATERAL PROCEDURE WITH THE LEFT SIDE UP. A SCHANZ PIN WAS PLACED IN LEFT PSIS AND 3DEFINE ATTEMPT WAS SUCCESSFUL. THE ARM WAS THEN SENT TO DRAPE FOR DRAW SPINE, BUT AN ERROR MESSAGE INDICATED THAT DRAPE POSITION WAS UNREACHABLE. THE 3D WORKING VOLUME WAS THOUGHT TO HAVE BEEN THE REASON FOR THIS. THE ARM WAS REMOUNTED WITH THE ELBOW JOINT ANGLE ADJUSTED SLIGHTLY. THE SECOND 3DEFINE WAS SUCCESSFUL AND THE ARM WAS SUCCESSFULLY SENT TO DRAPE MODE. DRAW SPINE WAS SUCCESSFUL. 3D MARKER SENT TO AP. THE 3D MARKER WAS ADJUSTED ANTERIOR TO BETTER CAPTURE THE AP. ERROR 295 APPEARED WHEN ATTEMPTING TO SEND THE ARM TO TAKE OBL IMAGE: ¿OBL POSITION IS UNREACHABLE. CONSIDER RE-DRAWING SPINE USING A DIFFERENT VERTEBRAL BODY.¿ THE ARM WAS MANIPULATED POSTERIOR AND THEN SUCCESSFULLY SENT TO THE OBL I

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A GUIDANCE DEVICE BEING USED IN A SPINAL PROCEDURE. IT WAS REPORTED THAT THE SURGEON PERFORMED AN L3-5 LATERAL MAZOR X CASE. PREPLANNING WAS DONE WITH THE SURGEON PRIOR TO THE PROCEDURE. SPECIAL ATTENTION WAS PAID TO AXIAL ANGLES AND SKIVE POTENTIALS. L3-5 OLIF WAS PERFORMED PRIOR TO USING THE MAZOR X. THE PATIENT WAS POSITIONED FOR A LATERAL PROCEDURE. THE SCHANZ PIN WAS PLACED IN LEFT PSIS. AND THE SCHANZ ARM WAS ATTACHED. 3DEFINE AND DRAW SPINE WERE SUCCESSFUL. REGISTRATION WAS SUCCESSFUL USING AUTO REGISTRATION AND THE BASIC ALGORITHM. ALL 6 WIRES WERE PLACED STARTING WITH RIGHT L3. ALL RIGHT SIDE TRAJECTORIES WERE INSTRUMENTED PRIOR TO LEFT SIDE TRAJECTORIES. LATERAL CONFIRMATION FLOURO IMAGES WERE TAKEN FOR EACH TRAJECTORY AND APPEARED ACCURATE. A FINAL AP CONFIRMATION SHOWED RIGHT L3 WAS LATERAL. RIGHT L3 WAS ADJUSTED IN THE PLAN AND DRILLED AGAIN. FINAL AP AND LATERAL FLOURO IMAGES WERE TAKEN AND ALL 6 SCREWS APPEARED TO BE PLACED ACCURATELY. THE POST-OP CT SHOWED LEFT SIDE SCREWS MISPLACED MEDIALLY AND RIGHT SIDE SCREWS MISPLACED LATERALLY. UPON CASE COMPLE

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A GUIDANCE DEVICE BEING USED IN A SPINAL PROCEDURE. IT WAS REPORTED THAT THE PLAN FOR THE CASE WAS TO PERFORM A SCAN AND PLAN AND EXECUTE SCREWS AT T11, T12, L2, AND L3. THIS WAS TO BACK UP A L1 BURST FRACTURE. ONCE THE SURGEON EXPOSED THE REGION OF INTEREST, THE REP SUGGESTED USING THE DUAL CLAMP AND CLAMPING AT T12 AND L2 SPINOUS PROCESSES. THIS WAS TO AVOID THE INSTABILITY OF L1. THE DUAL CLAMP WAS PLACED, 3DEFINE PERFORMED, SNAPSHOT TAKEN AND THEN STAR MARKER PLACED. DUE TO THE SIZE OF THE PATIENT AND HEIGHT OF THE DUAL CLAMP, IT TOOK THREE SPINS OF THE O-ARM TO ACHIEVE REGISTRATION. SCREWS WERE THEN PLANNED AND REVIEWED WITH THE SURGEON. THORACIC SCREWS WERE PLANNED BETWEEN 8-10 DEGREES OFF MIDLINE TO ACCOUNT FOR ANY SOFT TISSUE PROBLEMS, WITH LUMBAR SCREWS PLANNED SLIGHTLY MORE LATERAL. THE REP NOTED THE SMALL PEDICLES TO THE SURGEON AND ASKED IF THEY WOULD LIKE TO ADJUST TO 4.5MM SCREWS AND THEY OPTED TO KEEP THEM AT 5.5MM. THE SCREWS WERE THEN EXECUTED STARTING WITH T11 ON THE RIGHT AND WORKING DOWN, FOLLOWED BY T11 ON THE LEFT AND WORKING DOWN. NAVIGATION S

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A GUIDANCE DEVICE BEING USED IN A SPINAL PROCEDURE. IT WAS REPORTED THAT SHOULDER WILL NOT LOCK VIA PHYSICAL BUTTON OR SOFTWARE BUTTON. IT WAS NOTED THERE WAS NO PATIENT HARM BUT THE CASE WAS ABORTED. THERE WERE NO ADDITIONAL COMPLICATIONS REPORTED OR ANTICIPATED AS A RESULT OF THE EVENT.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A GUIDANCE DEVICE BEING USED IN A SPINAL PROCEDURE. IT WAS REPORTED THAT THEY WERE DOING THE FIRST CASE WITH THE DEVICE ON THE DAY OF THE REPORT. THEY STARTED WITH L45 AND L3-4 INTRALIFS. THE L4-5 LEVEL WAS CONDUCTED AS A TRUE INTRALIF UTILIZING THE TRAJECTORY OF THE ROBOT ARM. THE HCP REMOVED THE INTERNAL DISSECTOR AND PLACED A 7.5 MM AND 6.5 MM DILATOR FROM JOIMAX AND PASSED A K-WIRE THROUGH IT. THEN, THEY TOOK OUT THE DILATORS AND PASSED THROUGH A GLOBUS 8/5 MM TUBE THAT WAS SURE-TRACKED. THE HCP USED THE ROBOT TO GUIDE TO BOTH DISC SPACES. IT WAS NOTED THAT THE ROBOT SYSTEM AND NAVIGATION PERFORMED AS PLANNED. THE DILATOR WAS ACCURATE ON THE NAVIGATION WHEN USED WITH THE INSTRUMENTS. THE PATIENT HAD A LEFT L3 NEUROPRAXIA. THE PSOAS BELLY WAS MORE POSTERIOR THAN THE HCP THOUGHT. IT WAS NOTED THAT THE INTRALIF MAY NEED NEUROMONITORING. THE LEFT L4-5 WENT SMOOTHLY BUT THE HCP DECIDED TO BE A LITTLE EXTRA FORAMINAL FOR L3-4. IT WAS NOTED THE HCP MAY HAVE CONVERTED THE INTRALIF ALMOST INTO A ROBOT-GUIDED ENDOSCOPIC XLIF. THERE WERE NO ADDITIONAL COMPLICATIONS REPORTE

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A GUIDANCE DEVICE BEING USED IN A SPINAL PROCEDURE. IT WAS REPORTED THAT THE TRAJECTORIES WERE LOW ON FIVE OF THE LAST 6 CASES. THE HCP PERFORMED AN MIS TLIF. THE ROBOT WAS SENT TO THE L5 AND S1 TRAJECTORIES ON THE LEFT AND RIGHT, THE SKIN WAS MARKED AND THEN INCISION WAS MADE. THE INNER AND OUTER DRILL GUIDE WAS PLACED AND THE PEDICLE WAS DRILLED. THE REDUCTION TUBE WAS INSERTED AND GUIDEWIRES PLACED THROUGH THE TUBES. THE C ARM WAS BROUGHT IN TO VERIFY GUIDEWIRE PLACEMENT. IT WAS NOTED THAT THE WIRES APPEARED LOW BUT SHOULD BE OK. A TLIF WAS PERFORMED AND THEN SCREWS INSERTED USING FLUOROSCOPY. ON SUNDAY (B)(6) 2019 THE PATIENT HAD TO BE BROUGHT BACK TO THE OR TO REMOVE THE L5 AND S1 SCREWS ON THE PATIENTS LEFT SIDE AS THEY WERE LOW AND THE L5 SCREW APPEARED TO BE IN THE FORAMEN. IT WAS DEEMED THAT THE SCREWS ON THE PATIENTS RIGHT SIDE WERE LOW BUT WERE STILL IN THE PEDICLE SO WERE LEFT IN. THERE WERE NO ADDITIONAL COMPLICATIONS REPORTED OR ANTICIPATED AS A RESULT OF THE EVENT.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A GUIDANCE DEVICE BEING USED IN A SPINAL PROCEDURE. IT WAS REPORTED THAT THERE WERE 3 MISPLACED SCREWS WITH CANAL BREECHES AND DURAL TEARS. IT WAS NOTED THAT EXTREME SOFT TISSUE PRESSURE AND POOR TECHNIQUE LEAD TO THE EVENT. IT WAS NOTED THAT THE NAVIGATION DID NOT DEPICT THE DEVIATIONS TRUE AS THEY OVERLAID THE ARM TRAJECTORY AND GAVE A FALSE SENSE OF SECURITY. IT WAS NOTED THAT THE SURGERY WAS COMPLETED WITH FREE HAND NAVIGATION. ADDITIONAL INFORMATION RECEIVED FROM THE REP INDICATED THAT THE SCREW PLACEMENT WAS 10-11MM MIDLINE. CONTRIBUTING FACTORS TO THE TECHNIQUE ISSUES INCLUDED A DEEP BIG PATIENT AND LOTS OF TISSUE PRESSURE. MICROSCOPE AND SUTURE TO REPAIR TEARS WAS DONE TO RESOLVE THE DURAL TEARS. THERE WERE NO ADDITIONAL COMPLICATIONS REPORTED OR ANTICIPATED AS A RESULT OF THE EVENT.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: MEDTRONIC RECEIVED INFORMATION FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A GUIDANCE DEVICE BEING USED IN A SPINAL PROCEDURE. IT WAS REPORTED THAT 3DEFINE FAILED DURING THE PROCEDURE. A SECOND 3DEFINE WAS SUCCESSFUL. REGISTRATION WAS PERFORMED QUICKLY. UPON INSTRUMENTING FIRST TRAJECTORY (LEFT L4), THE WORKSTATION BEEPED AND GAVE AN INSTRUCTION TO LOCK THE ARM IN THE SOFTWARE. THE SURGEON DID NOT HAVE TOOLS IN THE ARM GUIDE WHEN THIS NOTIFICATION OCCURRED. THE ARM WAS RELOCKED IN THE SOFTWARE AND ANOTHER 3DEFINE WAS PERFORMED. THE 3DEFINE FAILED AGAIN ON THE FIRST ATTEMPT. THE SECOND ATTEMPT FOR 3DEFINE WAS SUCCESSFUL. REGISTRATION WAS PERFORMED QUICKLY, AND SURGEON INSTRUMENTED ALL 4 TRAJECTORIES. AP AND LATERAL X-RAY IMAGES VERIFIED WIRES WERE ACCURATELY PLACED. TWO DAYS FOLLOWING THE CASE, THE REP RECEIVED NOTIFICATION THAT THE RIGHT L4 SCREW HAD BEEN MISPLACED LATERAL AND SUPERIOR. REVISION PROCEDURE WAS SCHEDULED FOR SATURDAY (B)(6) 2019 TO REMOVE SCREW AND PLACE NEW ONE. IT WAS ALSO NOTED THAT THE WORKSTATION WOULD NOT ALLOW IMPORT OR EXPORT OF ANY DATA. THE PATIENT COMPLAINED OF RIGHT LEG PAIN POST OPERATIVELY. ADDITIONAL INFORMATI