BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SM FRAG LOCKING PLATE HS Y

    MDR report key: 1030384 · Received April 16, 2008

    Report

    Report Number
    1818910-2008-01095
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Report Date
    March 17, 2008
    Manufacturer
    HARD INNOVATIONS LLC
    Product Code
    KTT
    PMA / PMN Number
    K061748
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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

    X RAY SHOWS PLATE HAS FRACTURED PROXIMAL END IN MIDDLE, REVISION SURGERY HAS NOT BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SM FRAG LOCKING PLATE HS Y 87KTT KTT HARD INNOVATIONS LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other