BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREAD LOCK MANDIBULAR ANGLE PLATE

    MDR report key: 1292599 · Received January 15, 2009

    Report

    Report Number
    9610905-2009-00001
    Event Type
    Injury
    Date Received
    January 15, 2009
    Date of Event
    September 17, 2007
    Report Date
    January 9, 2009
    Manufacturer
    KARL LEIBINGER GMBH U. CO. KG
    Product Code
    JEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    KLS MARTIN L. P. HAD NO PRIOR KNOWLEDGE OF THIS INCIDENT. IMPLANT HAS NOT BEEN RETURNED TO KLS MARTIN L.P. AND EVALUATION CAN NOT BE DONE AT THIS TIME. IF IMPLANT IS RETURNED, AN EVALUATION WILL BE COMPLETED BY THE MANUFACTURER.

    Description of Event or Problem · 1

    IN 2005, DR'S IMPLANTED A MANDIBULAR RECONSTRUCTIVE PLATE. PLATE FILED IN 2006, WAS REMOVED AND A PLATE REPORTED TO BE A KLS MARTIN PLATE WAS IMPLANTED. IN 2007, PT RETURNED IN PAIN, X-RAYS TAKEN FIVE DAYS LATER, REVEALED PLATE FAILED. SURGERY PERFORMED TWO MONTHS LATER, REMOVED PLATE, BONE GRAFT AND PLATING USED TO RECONSTRUCT MANDIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THREAD LOCK MANDIBULAR ANGLE PLATE BONE PLATE JEY KARL LEIBINGER GMBH U. CO. KG 50-195-21 30389168

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other