BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VUELOCK IMPLANTS

    MDR report key: 1377635 · Received March 6, 2009

    Report

    Report Number
    2242816-2009-00011
    Event Type
    Malfunction
    Date Received
    March 6, 2009
    Date of Event
    February 13, 2009
    Report Date
    February 20, 2009
    Manufacturer
    EBI, L.P.
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DHR WAS REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED.

    Description of Event or Problem · 1

    A LOCKING RING MALFUNCTIONED DURING SCREW INSERTION. A REPLACEMENT WAS USED. PATIENT OUTCOME: NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VUELOCK IMPLANTS KWQ EBI, L.P. 105547

    Patients

    Seq Age Sex Outcome Treatment
    1