BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY SCREW

    MDR report key: 1063261 · Received June 18, 2008

    Report

    Report Number
    1818910-2008-02397
    Event Type
    Injury
    Date Received
    June 18, 2008
    Report Date
    May 20, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HWC
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 INITIAL SURGERY WAS DONE WITH THE PLATE OF COMPETITIVE COMPANY FOR THE FRACTURE OF PROXIMAL TIBIA. AFTER THE SURGERY, TWO SCREWS WERE FOUND BROKEN JUST BELOW THE SCREW HEAD. THE DOCTOR THINKS THAT THE BONE UNION IS NOT ENOUGH, SO ANOTHER SURGERY TO REMOVE THE BROKEN SCREWS IS UNDER CONSIDERATION. WE CAN NOT CONFIRM WHICH TWO SCREWS ARE BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY SCREW TRAUMA DEVICE HWC DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR