BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE PLATE, MP, 4 HOLE, LONG BAR

    MDR report key: 2172334 · Received June 23, 2011

    Report

    Report Number
    8010177-2011-00179
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    May 5, 2011
    Report Date
    May 30, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K022185
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS, BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A REVISION SURGERY TO EXPLANT THE FRACTURED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE PLATE, MP, 4 HOLE, LONG BAR IMPLANT JEY STRYKER OSTEOSYNTHESIS FREIBURG NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR