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.