BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO PLATE, L-SHAPE, 100, LEFT, LONG, CP TITANIUM

    MDR report key: 108662 · Received July 3, 1997

    Report

    Report Number
    9610905-1997-00002
    Event Type
    Malfunction
    Date Received
    July 3, 1997
    Date of Event
    May 15, 1997
    Report Date
    July 3, 1997
    Manufacturer
    KARL LEIBINGER MEDIZINTECHNIK
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PLATES WERE ORIGINALLY IMPLANTED JANUARY 15, 1997. DURING EXAMINATION, THE PLATES WERE DISCOVERED TO BE BROKEN. A SECOND SURGERY WAS PERFORMED TO REPLACE THEM MAY 15, 1997. THE EVENT WAS NOT REPORTED UNTIL JULY 3, 1997.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICRO PLATE, L-SHAPE, 100, LEFT, LONG, CP TITANIUM Implant BONE PLATE HRS KARL LEIBINGER MEDIZINTECHNIK 25-314-85 20001833

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention