BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEAK FX PLATE 6 HOLE NS

    MDR report key: 1143608 · Received August 28, 2008

    Report

    Report Number
    1818910-2008-03463
    Event Type
    Injury
    Date Received
    August 28, 2008
    Date of Event
    July 29, 2008
    Report Date
    July 29, 2008
    Manufacturer
    DEPUY ACE S.A. 'R.L
    Product Code
    KTT
    PMA / PMN Number
    K063509
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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

    PATIENT WAS REVISED TO ADDRESS BROKEN PEAK FX PLATE. THE SURGEON WAS AWARE OF THE POSSIBILITY THAT THIS PLATE MAY BREAK USED IN PROXIMAL FEMUR FRACTURE WITH SUBTROCH EXTENSION. PEAK PLATE BROKE AT LAG SCREW/PLATE INTERFACE. ALSO, IN THE REVISION SURGERY, THE COLLAPSE CAP WAS COLD-WELDED TO THE LAG SCREW, AND THE LAG SCREW COULD NOT BE REMOVED. THIS RESULTED IN A 30-MINUTE EXTENSION OF SURGICAL TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEAK FX PLATE 6 HOLE NS 87KTT KTT DEPUY ACE S.A. 'R.L NA DHGCH2

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention