BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC MIDAS REX

    MDR report key: 5351022 · Received December 31, 2015

    Report

    Report Number
    MW5059034
    Event Type
    Injury
    Date Received
    December 31, 2015
    Date of Event
    December 8, 2015
    Report Date
    December 31, 2015
    Manufacturer
    MEDTRONIC POWERED SURGICAL
    Product Code
    HBB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MIDAS REX FOOTPLATE BROKE OFF DURING THE CRANIOTOMY FOR TUMOR. MIDAS REX LEGEND #8 IS THE SPECIFIC DRILL INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862007 MEDTRONIC MIDAS REX DUREGUARD HBB MEDTRONIC POWERED SURGICAL MEDT T9850/C0375 A0279

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention