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1 record match for Medtronic plc — Surgical Robotics
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Not graded by the source2022-08-10FDA MAUDEMW5111965Mazor X
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) 2022 THE PATIENT HAD SPINAL SURGERY WITH USE OF MAZOR ROBOTIC ASSISTANCE. PER THE SURGEON, DURING THE PROCEDURE THE EXPANDING TECHNOLOGY FAILED. ALSO POST OP, IT WAS SUSPECTED THAT THE SCREWS PLACED BY THE MAZOR WERE MALPOSITIONED FROM THE PLANNED TRAJECTORY. ANOTHER PROCEDURE WAS REQUIRED FOR SCREW REVISION AND COMPRESSION OF THE EXPANDABLE CAGE. FDA SAFETY REPORT ID # (B)(4).
cause not establishedMW5111965Medtronic plc — Surgical RoboticsRead the record ↗