BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC MIDAS REX 8

    MDR report key: 22039359 · Received May 16, 2025

    Report

    Report Number
    MW5170526
    Event Type
    Injury
    Date Received
    May 16, 2025
    Date of Event
    May 6, 2025
    Report Date
    May 13, 2025
    Manufacturer
    MEDTRONIC/ MEDTRONIC POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE MIDAS REX MR8 (NEW-OWNED) WAS BEING USED, THE DRILL BEGAN SHOWING SIGNS OF OVERHEATING AND BEING HOT TO THE TOUCH, MULTIPLE DRILLS WERE BROUGHT INTO THE ROOM ALL MIDAS REX MR8 AND MULTIPLE BURRS WERE UTILIZED, ALONG WITH COOLING DOWN PHASES BETWEEN USES, PER INSTRUCTIONS FOR USE (IFU) AND PAST ROOT CAUSE ANALYSIS(RCA) RECOMMENDATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166690 MEDTRONIC MIDAS REX 8 MOTOR, DRILL, PNEUMATIC HBB MEDTRONIC/ MEDTRONIC POWERED SURGICAL SOLUTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention MICRODISCECTOMY.