BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM

    MDR report key: 3623500 · Received February 11, 2014

    Report

    Report Number
    2520274-2014-00524
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Date of Event
    January 16, 2014
    Report Date
    January 16, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    PMA / PMN Number
    K050608
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS ADDITIONAL CODE: DZL. 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

    IT WAS REPORTED THAT A PATIENT WAS BEING TREATED FOR A LEFORT I OSTEOTOMY WITH INTERNAL FIXATION. THE SURGEON WAS INSERTING A MATRIX MIDFACE SCREW INTO A PLATE. ON THE FINAL TIGHTENING OF THE PLATE, A PIECE OF THE HEAD OF THE SCREW BROKE OFF. THE BROKEN PIECE WAS SUCTIONED. THE REMAINING PART OF THE SCREW WAS LEFT IMPLANTED. MOMENTS LATER IN THE SAME SURGERY, THE SURGEON USED PLATE CUTTERS TO CUT THE MIDFACE PLATE; THE PLATE CUTTER BROKE. SURGEON OBTAINED A PLATE CUTTER FROM ANOTHER PLATING SET, AND FINISHED THE CASE WITHOUT A PROBLEM. NO SURGICAL INTERVENTION WAS REQUIRED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT'S POST-OPERATIVE CONDITION WAS REPORTED AS GOOD. THIS REPORT IS 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89226 TI MATRIXMIDFACE SCREW SELF-DRILLING 6MM JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR