BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI PLATE, RIGID BLUE, 8 HOLE REGULAR

    MDR report key: 1064164 · Received June 11, 2008

    Report

    Report Number
    9610905-2008-00003
    Event Type
    Injury
    Date Received
    June 11, 2008
    Manufacturer
    KARL LEIBINGER GMBH U CO. KG
    Product Code
    JEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BROKEN IMPLANT WAS DISPOSED OF BY THE HEALTH CARE FACILITY. NO EVAL OF THE PRODUCT CAN BE PERFORMED. INFO PERTAINING TO THIS INCIDENT WAS PROVIDED BY THE HEALTH CARE FACILITY TO THE FDA AND THIS INFO WAS FORWARDED BY THE FDA TO KLS MARTIN. THIS INFO WAS RECEIVED BY KLS MARTIN L.P. ON THE 19TH OF MAY 2008.

    Description of Event or Problem · 1

    DR UTILIZED A TITANIUM PLATE TO FIXATE A FRACTURE IN THE MANDIBLE. IN 5 MONTHS POST IMPLANTATION, PT EXPERIENCED PAIN AND INSTABILITY OF THE MANDIBLE. PLATE WAS FOUND TO BE BROKEN AND SURGERY REMOVED PLATE AND FIXATION SCREWS. DUE TO FIBROUS UNION, NO FIXATION WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI PLATE, RIGID BLUE, 8 HOLE REGULAR BONE PLATE JEY KARL LEIBINGER GMBH U CO. KG 50-320-08

    Patients

    Seq Age Sex Outcome Treatment
    1 Other