BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN THREADED PEG

    MDR report key: 1090243 · Received July 30, 2008

    Report

    Report Number
    1818910-2008-03168
    Event Type
    Injury
    Date Received
    July 30, 2008
    Date of Event
    June 30, 2008
    Report Date
    June 30, 2008
    Manufacturer
    HAND INNOVATIONS LLC
    Product Code
    HWC
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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

    PT WAS REVISED BECAUSE THE SCREWS BACKED OUT OF THE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN THREADED PEG TRAUMA SCREW HWC HAND INNOVATIONS LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention