BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VUELOCK SCREW INSERTER

    MDR report key: 922094 · Received October 1, 2007

    Report

    Report Number
    2242816-2007-00046
    Event Type
    Malfunction
    Date Received
    October 1, 2007
    Date of Event
    September 12, 2007
    Report Date
    September 18, 2007
    Manufacturer
    EBI
    Product Code
    HXX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    INTERNAL DRIVER OF SCREW INSERTER SNAPPED OFF AND REMAINS IN THE HEAD OF SCREW. THE SCREW REMAINS IMPLANTED IN THE PT. PT STATUS: GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VUELOCK SCREW INSERTER HXX EBI M13038-01

    Patients

    Seq Age Sex Outcome Treatment
    1 YR