BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURVED PLATE, 5 HOLES, LEFT

    MDR report key: 1872228 · Received October 15, 2010

    Report

    Report Number
    8010177-2010-00386
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    September 13, 2010
    Report Date
    September 16, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    HRS
    PMA / PMN Number
    K063875
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROCESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    BROKEN 6 HOLE CURVED PLATE APPLIED FOR A MPJ FUSION. PLATE BROKEN AT PROXIMAL SCREW HOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURVED PLATE, 5 HOLES, LEFT IMPLANT HRS STRYKER OSTEOSYNTHESIS FREIBURG NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other