BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM TI LC-DCP PLATE 6 HOLES/51MM

    MDR report key: 1023283 · Received April 1, 2008

    Report

    Report Number
    3003506883-2008-00004
    Event Type
    Injury
    Date Received
    April 1, 2008
    Report Date
    March 6, 2008
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    JEY
    PMA / PMN Number
    K954385
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. SYNTHES IS UNABLE TO DETERMINE THE MFR DATE WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    A 2.4MM TI LC-DCP PLATE, IMPLANTED TO REPAIR A MANDIBLE FRACTURE, WAS NOTED AS BROKEN ON POST-OPERATIVE X-RAY. DURING REVISION SURGERY, THE BROKEN PLATE WAS REMOVED AND REPLACED WITH A LOCKING RECONSTRUCTION PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.4MM TI LC-DCP PLATE 6 HOLES/51MM MANDIBLE STRAIGHT PLATES JEY SYNTHES ELMIRA NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention SCREWS