BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXMANDIBLE 8H STRUT PL CURVED/MALLEABLE/1.0MM THICK

    MDR report key: 2900295 · Received January 7, 2013

    Report

    Report Number
    3003506883-2013-00020
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    JEY
    PMA / PMN Number
    K063790
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. PLACEHOLDER.

    Description of Event or Problem · 1

    A PATIENT SUFFERED A SEIZURE, FELL AND HIT HIS FACE ON THE GROUND RESULTING IN A MANDIBLE FRACTURE OF THE LEFT SIDE. THE PATIENT WAS IMPLANTED WITH MATRIX MANDIBLE PLATE ON (B)(6) 2012. WHILE INSERTING ONE OF THE SCREWS THE SCREW HEAD WENT COMPLETELY THROUGH THE HOLE OF THE PLATE. THIS SCREW WAS REMOVED AND THE PLATE WAS IMPLANTED WITH THE REMAINING SIX (6) SCREWS. THE PROCEDURE WAS COMPLETED WITH NO FURTHER PROBLEM. THERE WAS NO REPORTED HARM TO THE PATIENT. THIS REPORT IS #1 OF 2 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6386 TI MATRIXMANDIBLE 8H STRUT PL CURVED/MALLEABLE/1.0MM THICK TI MATRIXMAND 8H STRUT PL CURVED/MALLEABLE JEY SYNTHES ELMIRA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR SCREWS