BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIXMANDIBLE LOCKING SCREW, SELF TAPPING

    MDR report key: 1790149 · Received August 3, 2010

    Report

    Report Number
    1719045-2010-00202
    Event Type
    Injury
    Date Received
    August 3, 2010
    Report Date
    July 6, 2010
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JEY
    PMA / PMN Number
    K063790
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. THE FOLLOWING PART NUMBERS WERE IMPLANTED IN THE PATIENT. THE HOSPITAL AS UNABLE TO IDENTIFY WHICH PART NUMBER WAS ASSOCIATED WITH THE REPORTED EVENT: 04.503.638.01; 04.503.642.01; 04.503.644.01; 04.503.674.01. APPROXIMATE IMPLANT DATE - (B)(6) 2010. SURGEON PLANS TO RETURN PATIENT TO OPERATING ROOM FOR REVISION. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING DATE WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    SIX MONTHS POSTOP, X-RAYS SHOWED ALL FOUR PROXIMAL SCREWS DETACHED FROM THE PLATE FOR A MANDIBLE RECONSTRUCTION IMPLANTED APPROXIMATELY (B)(6) 2010. SURGEON PLANS TO RETURN PATIENT TO OPERATING ROOM FOR REVISION. SYNTHES PRODUCT DEVELOPMENT NOTES THESE SCREWS ARE NOT INTENDED TO BE USED WITH THE SUBJECT PLATE. THIS IS THE 2ND OF 5 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI MATRIXMANDIBLE LOCKING SCREW, SELF TAPPING TI MATRIXMANDIBLE LOCKING SCREW JEY SYNTHES MONUMENT NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention PLATE| SCREWS