BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DXTEND SCREW LOCK D4.5X30MM

    MDR report key: 1052445 · Received May 21, 2008

    Report

    Report Number
    1818910-2008-01603
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    April 21, 2008
    Report Date
    April 21, 2008
    Manufacturer
    DEPUY FRANCE S.A.
    Product Code
    KWS
    PMA / PMN Number
    K062250
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    DURING SURGERY, THE SCREW BROKE AT THE SCREW HEAD. THE THREADED PORTION WAS WELL FIXED AND LEFT IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DXTEND SCREW LOCK D4.5X30MM 87KWS KWS DEPUY FRANCE S.A. NA 2507482

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR