BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINE SCREW AND PLUGS

    MDR report key: 1151952 · Received September 5, 2008

    Report

    Report Number
    MW5008222
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    September 3, 2008
    Report Date
    September 5, 2008
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IMPLANT FAILURE. RT ROD AT L3 IN PLACE IN HEAD OF SCREW AND SET PLUG FOUND IN SOFT TISSUE. LT ROD L3 WAS OUT OF THE HEAD OF SCREW AND SET PLUG WAS STILL IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINE SCREW AND PLUGS KWQ MEDTRONIC SOFAMOR DANEK LT 7.5X50 WO7E2733

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S