BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIDAS REX

    MDR report key: 11176934 · Received January 15, 2021

    Report

    Report Number
    11176934
    Event Type
    Malfunction
    Date Received
    January 15, 2021
    Date of Event
    November 15, 2020
    Report Date
    January 4, 2021
    Manufacturer
    MEDTRONIC POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC POWERED SURGICAL SOLUTIONS MIDAS REX SURGICAL DRILL WAS USED FOR SURGERY. EVERY TIME IT WAS USED, THE PATIENT REFLEXED/JUMPED. A DIFFERENT MIDAS REX SURGICAL DRILL WAS OPENED AND USED AND THE PATIENT DID NOT JUMP/REFLEX ANYMORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78259 MIDAS REX MOTOR, DRILL, PNEUMATIC HBB MEDTRONIC POWERED SURGICAL SOLUTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1