BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 12MM

    MDR report key: 2860657 · Received December 6, 2012

    Report

    Report Number
    1719045-2012-01259
    Event Type
    Injury
    Date Received
    December 6, 2012
    Report Date
    November 8, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JEY
    PMA / PMN Number
    K063790
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    PATIENT IMPLANTED WITH MATRIX MANDIBLE RECONSTRUCTION PLATE AND SIX SCREWS ON (B)(6) 2011. ON AN UNKNOWN DATE, THE SURGEON'S DIAGNOSTICS REVEALED THREE SCREW HEADS WERE BROKEN FROM THE SCREW BODY BUT REMAINED SEATED THE LOCKING PLATE. ON (B)(6) 2012, THE SURGEON EXPLANTED THE THREE BROKEN LOCKING SCREW HEADS FROM THE PLATE, ADDED BONE GRAFT, REPOSITIONED THE PLATE, INSERTED THREE REPLACEMENT LOCKING SCREWS AND COMPLETED THE PROCEDURE. IT WAS REPORTED THAT THE PATIENT REFUSED BONE GRAFTING UPON THE ORIGINAL IMPLANT DATE. THIS IS 1 OF 3 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 12MM MATRIX MANDIBLE LOCKING SCREW JEY SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention SCREW X 3