BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.85MM TI MATRIX SCREW SELF-DRILLING/5MM

    MDR report key: 3251341 · Received July 29, 2013

    Report

    Report Number
    2520274-2013-04696
    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

    ACTUAL EVENT DATE NOT KNOWN. 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.

    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 14 OF 22 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353282 1.85MM TI MATRIX SCREW SELF-DRILLING/5MM JEY SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention