BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DORSAL SMARTLOCK DR PLATE, STANDARD, LEFT

    MDR report key: 2211666 · Received August 6, 2011

    Report

    Report Number
    8010177-2011-00231
    Event Type
    Malfunction
    Date Received
    August 6, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    HRS
    PMA / PMN Number
    K040022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTED PLATE WAS REMOVED BECAUSE IT BROKE IN PT 4 MONTHS POST OPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DORSAL SMARTLOCK DR PLATE, STANDARD, LEFT IMPLANT HRS STRYKER OSTEOSYNTHESIS FREIBURG NA L2300F1747

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR