BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DXTEND SCREW LOCK D4.5X24MM

    MDR report key: 1011317 · Received March 7, 2008

    Report

    Report Number
    1818910-2008-00716
    Event Type
    Malfunction
    Date Received
    March 7, 2008
    Date of Event
    February 7, 2008
    Report Date
    February 7, 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
    FR
    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 HEAD SCREW WAS BROKEN. THE SCREW WAS LEFT IN PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DXTEND SCREW LOCK D4.5X24MM 87KWS KWS DEPUY FRANCE S.A. NA 2393527

    Patients

    Seq Age Sex Outcome Treatment
    1 NA