BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L COMPRESSION PROFILE PLATE, T-SHAPE, BEVELLED, NA

    MDR report key: 2852267 · Received November 12, 2012

    Report

    Report Number
    8010177-2012-00251
    Event Type
    Malfunction
    Date Received
    November 12, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 17, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    HRS
    PMA / PMN Number
    K062498
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS BUT NOT YET COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PLATE BROKE DURING SURGERY. THE PLATE WAS BROKEN DURING MOLDING. ANOTHER PLATE WAS AVAILABLE AND WAS IMPLANTED TO COMPLETE THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L COMPRESSION PROFILE PLATE, T-SHAPE, BEVELLED, NA IMPLANT HRS STRYKER OSTEOSYNTHESIS FREIBURG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK