BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUE

    MDR report key: 93460 · Received May 22, 1997

    Report

    Report Number
    93460
    Event Type
    Injury
    Date Received
    May 22, 1997
    Date of Event
    May 8, 1997
    Report Date
    May 8, 1997
    Manufacturer
    DEPUE
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ORIF PLATE WAS IMPLANTED ON 122796, ON LEFT ULNA ON 050897 THE PLATE HAD TO BE REMOVED BECAUSE IT HAD BROKEN. THE BROKEN PLATE CAUSED PSEUDO - ARTHROSIS AND GROSS MOVEMENT AT THE FRACTURE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUE Implant ORIF PLATE HRS DEPUE 1905-38 569466

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization