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1 record match for Medtronic plc — Surgical Robotics
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Not graded by the source2026-02-03FDA MAUDEMW5183641Mazor X
Mazor X — Injury report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: AN 82-YEAR-OLD FEMALE UNDERWENT PLANNED THORACIC PERCUTANEOUS INSTRUMENTATION FOR AN UNSTABLE T5 FRACTURE USING ROBOTIC NAVIGATION. DURING THE PROCEDURE, ROBOTIC REGISTRATION WAS PROLONGED AND TECHNICALLY CHALLENGING. DURING PEDICLE SCREW PLACEMENT, LOSS OF RESISTANCE WITH CSF RETURN WAS NOTED AND INSTRUMENTATION WAS STOPPED. SHORTLY THEREAFTER, NEUROMONITORING SIGNALS WERE LOST, AND THE PATIENT EXPERIENCED A PULSELESS ELECTRICAL ACTIVITY (PEA) ARREST WITH RAPID RETURN OF SPONTANEOUS CIRCULATION FOLLOWING BRIEF RESUSCITATION. POST-EVENT EVALUATION DEMONSTRATED ACUTE MYOCARDIAL DYSFUNCTION WITH PATENT CORONARY ARTERIES AND IMAGING FINDINGS CONCERNING FOR THORACIC SPINAL CORD INJURY RELATED TO A MEDIAL PEDICLE BREACH. THE FOLLOWING DAY, THE SERVICE RECEIVED AN URGENT MANUFACTURER SAFETY NOTICE REGARDING ROBOTIC NAVIGATION SOFTWARE ACCURACY.
cause not establishedMW5183641Medtronic plc — Surgical RoboticsRead the record ↗