BEUDAMED
    FDA Adverse Event Injury Summary report: N

    L-PLATE, 100 DEGREE, 2MM BAR, RIGHT, GSP, 5 HOLE

    MDR report key: 931971 · Received October 23, 2007

    Report

    Report Number
    8010177-2007-00056
    Event Type
    Injury
    Date Received
    October 23, 2007
    Date of Event
    June 8, 2007
    Report Date
    September 4, 2007
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MACROSCOPIC AND MICROSCOPIC EXAMINATION REVEALED THAT PLATE BROKE BY EXCEEDING THE MATERIALS STRENGTH AFTER A FEW CYCLES UNDER VERY HIGH FORCES IN LOW CYCLE FATIGUE MODE. THE INVESTIGATION WITH SEM SHOWS ON THE FRACTURED SURFACES A LARGE PART OF FORCED RUPTURE, WHICH POINT TO ACTION OF HIGH FORCES.

    Description of Event or Problem · 1

    ORIGINALLY BELIEVED TO BE TWO PLATES WITH THE SAME PART NUMBER IN 8010177-2007-00049. AFTER INVESTIGATION REALIZED, IT WAS TWO DIFFERENT PART NUMBERS; THEREFORE, FILLING IS BEING DONE FOR SECOND PLATE. PLATE BROKE 8 WEEKS POST-OP AFTER UNCOMPLICATED LEFORT I PROCEDURE. REVISION WAS DONE WITH NEW IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L-PLATE, 100 DEGREE, 2MM BAR, RIGHT, GSP, 5 HOLE IMPLANT HRS STRYKER OSTEOSYNTHESIS FREIBURG UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention