BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.85MM TI MATRIX SCREW SELF-DRILLING/5MM

    MDR report key: 3251347 · Received July 29, 2013

    Report

    Report Number
    2520274-2013-04734
    Event Type
    Injury
    Date Received
    July 29, 2013
    Report Date
    July 11, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    JEY
    PMA / PMN Number
    K083388
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED AND A MANUFACTURING EVALUATION CAN NOT BE PERFORMED. NO CONCLUSION COULD BE DRAWN AS THE DEVICE IS NOT BEING RETURNED AND NO LOT NUMBER WAS PROVIDED. THIS DEVICE WAS USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RETURNED FOR A ONE WEEK FOLLOW-UP TO A LEFORT I OSTEOTOMY. THE SURGEON NOTICED AN OPEN BITE AND A MALOCCLUSION. THE REOPERATION WAS SCHEDULED FOR (B)(6) 2013 WHERE THE SURGEON REMOVED ALL THE HARDWARE. ALL THE HARDWARE WAS INTACT AND NOTHING WAS BROKEN. THE SURGEON RE-ESTABLISHED THE PROPER OCCLUSION AND REVISED WITH 2.0MM CORTEX SCREWS AND AN L-PLATE FOR RIGID FIXATION. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 22 OF 22 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353284 1.85MM TI MATRIX SCREW SELF-DRILLING/5MM JEY SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention