BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANDIBULAR FRACTURE PLATE, 6-HOLES

    MDR report key: 1910563 · Received November 19, 2010

    Report

    Report Number
    8010177-2010-00437
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 27, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K014263
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS DISCARDED, SO IT WILL NOT BE RETURNED. INVESTIGATION IN PROCESS, BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    SURGEON REMOVED PLATE DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MANDIBULAR FRACTURE PLATE, 6-HOLES IMPLANT JEY STRYKER OSTEOSYNTHESIS FREIBURG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other