BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.0 MM TI MATRIXMANDIBLE SCREW

    MDR report key: 2994021 · Received February 27, 2013

    Report

    Report Number
    1719045-2013-10012
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    SYNTHES (USA) MONUMENT
    Product Code
    JEY
    PMA / PMN Number
    K063790
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. ANY ADDITIONAL INFO RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. VISUAL INSPECTION OF THE SCREW REVEALED THE CROSS SLOT FEATURE WAS DAMAGED. THE RESET OF THE SCREW WAS FOUND TO BE IN NORMAL CONDITION. THE SCREW WAS FOUND TO BE IN ACCEPTABLE CONDITION WITH THE EXCEPTION OF THE AREA WITH THE DAMAGED CROSS SLOT.

    Description of Event or Problem · 1

    ORIGINAL SURGERY DUE TO MANDIBLE FRACTURE WAS PERFORMED ON (B)(6) 2011 AT (B)(6) MEDICAL CENTER IN (B)(6). PT WAS IMPLANTED WITH A PLATE (04.503.750) AND 4 SCREWS (04.503.406 X 2 AND 04.503.408 X 2). PT WAS ASYMPTOMATIC - DID NOT COMPLAINT OF ANY PAIN. POST-OPERATIVE X-RAYS WERE TAKEN ON (B)(6) 2010 TO ENSURE REMOVAL OF ALL METAL AFTER ARCH BAR REMOVAL. IT WAS NOTED ON THE X-RAYS THAT THE PLATE WAS BROKEN. PT WAS REVISED THE SAME DAY ((B)(6) 2011). PLATE AND 4 SCREWS WERE REMOVED. THE PLATE APPEARS TO BE BROKEN THROUGH ONE OF THE MEDICAL SCREW HOLES. THE SCREWS ARE IN NORMAL CONDITION. SURGEON DID NOT IMPLANT ANY NEW HARDWARE AFTER REMOVING THE PLATE AND THE SCREWS, AS THE FRACTURE WAS HEALED. THIS COMPLAINT IS ON THE 1ST SCREW (04.503.406). THIS IS FOUR OF FOUR REPORTS FOR THIS EVENT. MEDWATCH# (B)(4) PREVIOUSLY FILED FOR THE BROKEN PLATE 04.503.750.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84428 2.0 MM TI MATRIXMANDIBLE SCREW JEY SYNTHES (USA) MONUMENT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention 2.0 MM TI MATRIXMANDIBLE SCREW (3)