BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEVEL ONE CMF

    MDR report key: 6191459 · Received December 20, 2016

    Report

    Report Number
    9610905-2016-00055
    Event Type
    Injury
    Date Received
    December 20, 2016
    Date of Event
    November 16, 2016
    Report Date
    December 5, 2016
    Manufacturer
    KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG
    Product Code
    MQN
    UDI-DI
    00888118078216
    PMA / PMN Number
    K032442
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS PERFORMED USING VISUAL AND STEREO MICROSCOPIC INSPECTION OF THE RETURNED PLATE. TENSILE CRACKS WERE OBSERVED UNDER THE STEREO MICROSCOPE. FURTHER OBSERVATION DETERMINED THERE WERE NO INDICATIONS OF MATERIAL OR MANUFACTURING DEFECTS. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED SINCE NO LOT NUMBER WAS PROVIDED BY THE REPORTER. THE RESULTS OF THE INVESTIGATION CONCLUDE THAT THE ROOT CAUSE FOR THE BREAKAGES WERE DUE TO MECHANICAL OVERLOAD ON THE DEVICE. IF FURTHER INFORMATION IS OBTAINED THAT MIGHT ADD VALUE TO THE CONTENTS OF THE INVESTIGATION REPORT, AN ADDITIONAL FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    PLATE BROKE INSIDE PATIENTS MOUTH. PATIENT CLAIMS TO HAVE BEEN MOVING HER JAW FROM SIDE TO SIDE A LOT AND WAS DOING THIS AT THE TIME THE PLATE BROKE. THE BREAK WAS AT NON UNION BETWEEN FIBULA FREE FLAP AND NATIVE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840517 LEVEL ONE CMF PLATE MQN KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG 50-760-26-09 UNKNOWN 00888118078216

    Patients

    Seq Age Sex Outcome Treatment
    1 Other