BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.85MM TI MATRIX SCREW

    MDR report key: 3980296 · Received August 5, 2014

    Report

    Report Number
    2520274-2014-12973
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 8, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    PMA / PMN Number
    PK083388
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SCREWS AND PLATE WERE IMPLANTED, BUT NEEDED TO BE REPOSITIONED DURING THE PRIMARY BILATERAL SAGITTAL SPLIT RAMUS OSTEOTOMY (BSSRO) PROCEDURE. WHEN SCREWS WERE REMOVED THE SCREW HEADS STRIPPED OUT. THE PLATE WAS THEN REPOSITIONED AND REFIXATED. NO EFFECT TO THE PATIENT ASIDE FROM MINIMAL EXTENSION OF OR TIME/ANESTHESIA, (ONE MINUTE). BROKEN FRAGMENTS WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION AND PROCEDURE WAS SUCCESSFULLY COMPLETED. ANTICIPATED TREATMENT IS NOT REQUIRED. THIS COMPLAINT INVOLVES TWO DEVICES. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456988 1.85MM TI MATRIX SCREW BONE PLATE JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR