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Death reported2023-03-03FDA MAUDEMedtronic plc — Surgical RoboticsMazor X3005075696-2023-00017Mazor X
Mazor X — Death 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 THE MANUFACTURER REPRESENTATIVE WAS SETTING UP FOR A CASE WHEN THE PATIENT PASSED AWAY WHILE THE SURGEON WAS DOING THE INTERBODY PLACEMENT PORTION OF THE PROCEDURE. THE REPRESENTATIVE HAD TURNED THE SYSTEM ON AND ENTERED THE KIT CODE IN PREPARATION FOR ITS USE. THE SYSTEM WAS NOT MOUNTED TO THE BED. NO MEDTRONIC HARDWARE OR EQUIPMENT WAS USED PRIOR TO THE PATIENT PASSING AWAY. THE PROCEDURE WAS NO DELAYED.
cause not established3005075696-2023-00017Medtronic plc — Surgical RoboticsMazor XRead the record ↗