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Death reported2026-02-03FDA MAUDEMedtronic plc — Surgical RoboticsMazor X3005075696-2026-00049Mazor X
Mazor X — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE SURGEON'S TECHNIQUE WAS DRILL, TAP, THEN SCREW. THE SURGEON OPERATED AND STARTED ON THE RIGHT SIDE. T3 AND T4 WERE PLACED WHEN AN INACCURACY WAS NOTICED. IT WAS ALSO NOTED THAT WITH REGISTRATION AND AFTER RE-IMAGING, THEY HAD A YELLOW VALUE BUT THEY WERE UNSURE WHAT LEVEL THIS WAS ON. ADDITIONALLY, IT WAS NOTED THAT THE PATIENT HAD A PRE-EXISTING FRACTURE AT T5.
cause not established3005075696-2026-00049Medtronic plc — Surgical RoboticsMazor XRead the record ↗