BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIXMAND RECO-PL STRAIG 12HO T2.5 TI

    MDR report key: 3173891 · Received June 17, 2013

    Report

    Report Number
    2520274-2013-03503
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Report Date
    November 14, 2011
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    PMA / PMN Number
    K063790
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN DEVICE WAS RETURNED INCOMPLETE. A REVIEW OF THE DEVICE HISTORY RECORDS WAS NOT PERFORMED BECAUSE NO LOT NUMBER WAS PROVIDED AND IT WAS NOT AVAILABLE ON THE RETURNED PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER INSERTING THE PLATE A NUMBER OF SCREWS COULD NOT BE UNSCREWED IN THE MANDIBLE FOR REPOSITIONING, THE SCREWS CANNOT BE TURNED OUT AND HAD TO BE DRILLED OUT. PART OF THE PLATE REMAINS IMPLANTED. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4). THIS REPORT IS ON THE PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273636 MATRIXMAND RECO-PL STRAIG 12HO T2.5 TI JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1