BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE PLATE, MP, 6 HOLE, CURVED, BAR LENGTH 14.8MM

    MDR report key: 1864605 · Received October 7, 2010

    Report

    Report Number
    8010177-2010-00367
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 8, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K022185
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROCESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    PER SALES REP: PLATE FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BONE PLATE, MP, 6 HOLE, CURVED, BAR LENGTH 14.8MM IMPLANT JEY STRYKER OSTEOSYNTHESIS FREIBURG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK