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

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: FOLLOWING A SURGERY USING MAZOR X SYSTEM, AT (B)(6) INTERNATIONAL HOSPITAL (B)(6), ON (B)(6) 2019, IT WAS REPORTED THAT WHILE USING THE SYSTEM TO DIRECT DRILLING INTO A VERTEBRA FROM A POSTERIOR DIRECTION, THE VERTEBRAL BODY WAS BREACHED ANTERIORLY AND PERFORATED THE INFERIOR VENA CAVA (IVC). L3-L5 SCREW PLACEMENT WAS PLANNED INTRA-OPERATIVELY USING O-ARM IMAGING. DURING THE PROCEDURE, L3L AND L4L WERE DRILLED USING THE SHORT DRILL GUIDE AND SHORT DRILL BIT. AS SURGEON FELT K-WIRE WAS DEVIATED, INDICATED BY BLOODSTAIN AND BONE ON THE DRILL, FURTHER X-RAY AND 3D IMAGING CONFIRMED THE DRILLS PERFORATED THE FRONT VERTEBRAL BODY. MAZOR X PROCEDURE WAS ABORTED. PATIENT UNDERWENT CT SCAN AND FOUND TEAR VEIN AND BLOOD CONGESTION NEARBY INFERIOR VENA CAVA. THE CLINICAL INVESTIGATION HAD SHOWN THE TRAJECTORIES EXECUTED WERE ACCURATE WITHIN THE PEDICLE AND PER PLAN, IN BOTH AXIAL & SAGITTAL PLANES. AS THERE ARE NO ISSUES OF ABNORMAL ANATOMY OR PLATFORM MOUNTING OR EVIDENCE FOR MALFUNCTION, IT WAS CONCLUDED THAT THE ROOT CAUSE FOR THE ANTERIOR BREACHING DURING THE MAZOR X PROCEDURE IS INCORRECT HARDWARE USE. IT IS PROBABLE THAT THERE WAS DEVIATION FROM SURGICAL TECHNIQUE, MANIFESTED AS USING

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING THE L3-L5 TLIF PROCEDURE, PERFORMED ON (B)(6) 2018, ALL TRAJECTORIES WERE CONFIRMED TO BE ACCURATE, AND NO SPECIAL ISSUES OCCURRED. HOWEVER, IN FOLLOW-UP EXAMINATION PERFORMED AFTER 2 MONTHS (COMPANY AWARENESS DATE (B)(6) 2019), THE SURGEON HAS NOTICED THAT SCREWS HAVE DEVIATED LATERALLY, REQUIRING ADDITIONAL REVISION SURGERY FOR THEIR CORRECTION. CLINICAL INVESTIGATION CONCLUDED THAT THERE IS NO MALFUNCTION EVIDENCE.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A COMPLAINT WAS RECEIVED ON (B)96) 2018 FROM (B)(6). DESCRIBING A SITUATION IN WHICH A TRAJECTORY DEVIATION OCCURRED AND RESULTED IN PENETRATION OF CEMENT INTO THE CANAL. THE SURGERY CONTINUED AS PLANNED AND THE PATIENT WAS FINE.

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 A 3DEFINE SCAN WAS COMPLETED AND REGISTRATION WAS ACHIEVED WITH AN O-ARM. LEFT AND RIGHT L2 WERE MEDIAL DUE TO SOFT TISSUE PRESSURE. THE RIGHT L2 TRAJECTORY PENETRATED THE DURA AND THE NERVE ROOT. THE CASE WAS ABORTED AFTER CONFIRMATION OF RIGHT L2 DEVIATION.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING A SURGICAL PROCEDURE USING THE MAZOR X SYSTEM AT (B)(6) HOSPITAL CENTER (US), ON (B)(6) 2018, (REPORTED TO MAZOR ON APR. 23, 2018), INACCURATE SCREW PLACEMENT RESULTED IN A REVISION SURGERY.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: DURING SURGICAL PROCEDURE USING THE MAZOR X SYSTEM AT (B)(6) HEALTHCARE (US) ON (B)(6) 2017 MEDIAL TRAJECTORY AT L4 DUE TO SOFT TISSUE PRESSURE FROM BILATERAL RETRACTOR RESULTED IN PROLONGATION OF MORE THAN AN HOUR DUE TO THE NEED TO REVISE THE TRAJECTORY. INVESTIGATION CONCLUDED THAT THE DEVICE DID NOT MALFUNCTION AND RELATED RISKS ARE WITHIN THE RISK ANALYSIS.

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) 2017 (REPORTED TO MAZOR ON (B)(4) 2017) THE MAZOR X SYSTEM WAS USED AT (B)(6) FOR A L4-S1 SURGERY. THE REPORTED EVENT: "WE HAD A SCREW BREACH MEDIAL DURING THE CASE AT SCRIPPS MEMORIAL ON (B)(6) WITH DR. (B)(6). AT THE TIME, DR. (B)(6) REMOVED THE SCREW AND REDIRECTED FREEHAND. THE NEW SCREW WAS CONFIRMED VIA FLURO AND NEUROMONITORING. ALL SIGNALS LEAVING THE CASE WERE OK. HOWEVER, DR. (B)(6) INFORMED ME LAST NIGHT THAT THE PATIENT WOKE UP WITH SOME LEFT SIDED SYMPTOMS AND FOOT DROP." UPDATE FROM (B)(6): PURSUANT TO DISCUSSION WITH THE SURGEON, HE HAS INFORMED THAT A COUPLE OF DAYS AFTER THE SURGERY THE PAIN HAS LESSENED BUT THE PATIENT STILL HAD PALSY.

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) 2017, AT (B)(6) HOSPITAL (US), DR. (B)(6) PERFORMED AN L3-S1 FUSION SURGERY USING THE MAZOR X SYSTEM. INTRAOPERATIVELY THE SCREWS LOOKED ACCURATE, BUT POST-OPERATIVELY THE PATIENT SUFFERED FROM A DROP-FOOT. ON A POST-OP CT IT WAS NOTED THAT L3-L4 TRAJECTORIES WERE MEDIAL AND THESE WERE REVISED THE FOLLOWING DAY. THIS WAS REPORTED TO MAZOR ON (B)(4) 2017.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: A COMPLAINT WAS RECEIVED ON (B)(6) 2017, FROM (B)(6) DESCRIBING A SITUATION IN WHICH A PROCEDURE (PERFORMED ON (B)(6) 2017) WENT WELL USING THE MAZOR X SYSTEM. THE SURGEON CONFIRMED THE ACCURACY OF PLACEMENT OF ALL THE PEDICLE SCREWS WHICH WERE PLACED WITH THE GUIDANCE OF THE MAZOR X SYSTEM WITH INTRAOPERATIVE FLUORO CONFIRMATION IMAGES. NEURO-MONITORING WAS ALSO EMPLOYED AND DID NOT INDICATE A BREACH OF THE PEDICLE. HOWEVER, THE NEXT DAY THE PATIENT COMPLAINED OF LEG/RADICULAR NERVE PAIN AND WAS TAKEN BACK TO THE HOSPITAL. THE SURGEON THEN INDICATED THAT SCREWS ON THE RIGHT SIDE WERE MEDIAL, WITH ONE OR MORE IN THE CANAL. THE SURGEON PERFORMED A REVISION AND REPOSITIONED THE SCREWS IN L3 AND L4 BY FREEHAND.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: FOLLOWING A SURGICAL PROCEDURE USING THE MAZOR X SYSTEM AT (B)(6), BACK ON (B)(6) 2017, IT WAS REPORTED TO MAZOR (ON (B)(6) 2018) BY (B)(4), THE MAZOR X DISTRIBUTOR, THAT THE PATIENT COMPLAINED THROUGH (B)(4) FACEBOOK THAT DURING THIS CASE NEARLY HALF OF THE SCREWS THAT WERE PLACED FROM T10-S1 WERE MISALIGNED TO VARYING DEGREES. THE SURGEON DECIDED TO DO A REVISION ON (B)(6) 2017. DURING THE REVISION SURGERY THE SURGEON REMOVED ALL THE DEVIATED SCREWS AND DID NOT PLACE NEW SCREWS OR ANY HARDWARE INSTEAD. THE CUSTOMER COMPLAINS ABOUT UNBEARABLE PAIN AND THE NEED TO DO ADDITIONAL REVISION SURGERIES IN THE NEAR FUTURE.

Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ABSTRACT: WE SOUGHT TO COMPARE INTRAOPERATIVE SURGICAL INSTRUMENTATION TECHNIQUES WITH IMAGE-GUIDANCE VERSUS ROBOTIC-GUIDED PROCEDURES FOR POSTERIOR SPINAL FUSION. METHODS: A RETROSPECTIVE REVIEW OF INSTITUTIONAL DATA COLLECTED FROM A SINGLE SURGEON WAS USED TO COMPARE SURGICAL OUTCOMES BETWEEN O-ARM NEURONAVIGATION AND THE MAZOR X ROBOTIC-ASSISTANCE SYSTEM FOR PLACEMENT OF POSTERIOR SPINAL INSTRUMENTATION IN A CONSECUTIVE SERIES OF PATIENTS. UNIVARIATE STATISTICAL SIGNIFICANCE TESTING COMPARED TIME SPENT IN THE OPERATING ROOM, BLOOD LOSS, SCREW ACCURACY, AND WOUND HEALING. RESULTS: BETWEEN JANUARY 2017 AND FEBRUARY 2019, 46 O-ARM CASES (MEAN AGE 59.6 YEARS ± 13.7 YEARS) AND 39 MAZOR X CASES (MEAN AGE 59.5 YEARS ± 12.4 YEARS) WERE CONDUCTED. CASES WERE CLASSIFIED AS DEGENERATIVE, INFECTIOUS, ONCOLOGIC, AND TRAUMA WITH A MEAN OF 4.57 AND 5.43 LEVELS OPERATED ON USING O-ARM NEURONAVIGATION AND MAZOR X, RESPECTIVELY. MEAN OPERATIVE TIMES (P = 0.124), ESTIMATED BLOOD LOSS (P = 0.212), WOUND REVISION RATES (P = 0.560), AND CLINICALLY ACCEPTABLE INSTRUMENTATION PLACEMENT (P = 0.076) DID NOT DEMONSTRATE SIGNIFICANCE BETWEEN THE 2 GROUPS. HOWEVER, SCREW PLACEMENT WAS SIGNIFICANTLY MORE A C