BEUDAMED
    FDA Adverse Event Other Summary report: N

    COMMAND STRAIGHT, SHORT 6 HOLE BONE PLATE

    MDR report key: 526405 · Received May 19, 2004

    Report

    Report Number
    8010177-2004-00009
    Event Type
    Other
    Date Received
    May 19, 2004
    Manufacturer
    STRYKER LEIBINGER GMBH & CO. KG
    Product Code
    JEY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ALLEGEDLY, PLATE BROKE 7 WEEKS AFTER INITIAL IMPLANT, RESULTING IN A REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMMAND STRAIGHT, SHORT 6 HOLE BONE PLATE BONE PLATE JEY STRYKER LEIBINGER GMBH & CO. KG 54-15046 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention