BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL PLATE 12 HOLE LEFT

    MDR report key: 1903247 · Received November 12, 2010

    Report

    Report Number
    1818910-2010-08400
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    September 20, 2010
    Report Date
    October 15, 2010
    Manufacturer
    DEPUY ACE S.A. 'R.L.
    Product Code
    HRS
    PMA / PMN Number
    K060969
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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

    THE SCREWS WERE NOT LOCKING INTO THE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL PLATE 12 HOLE LEFT 87HRS HRS DEPUY ACE S.A. 'R.L. NA DLHCRD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention