BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND SCREW LOCK D4.5X42MM

    MDR report key: 1033940 · Received April 24, 2008

    Report

    Report Number
    1818910-2008-01172
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    March 27, 2008
    Report Date
    March 27, 2008
    Manufacturer
    DEPUY FRANCE S.A.
    Product Code
    HSD
    PMA / PMN Number
    K062250
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 HEAD BROKE DURING IMPLANTATION AND COULD NOT BE REMOVED OR FULLY SEATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DXTEND SCREW LOCK D4.5X42MM 87HSD HSD DEPUY FRANCE S.A. NA 2480432

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention