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