BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASS MIS

    MDR report key: 5438415 · Received February 16, 2016

    Report

    Report Number
    1000432246-2016-00003
    Event Type
    Injury
    Date Received
    February 16, 2016
    Date of Event
    January 22, 2016
    Report Date
    February 16, 2016
    Manufacturer
    MEDICREA INTERNATIONAL
    Product Code
    MNI
    PMA / PMN Number
    K112493
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE HEXAGON OF THE NUT IN CONNECTION WITH THE NUT DRIVER WAS PROABABLY DAMAGED DURING AN OPERATION OF TIGHTENING. IF THE NUT DRIVER IS NOT IN ALIGNMENT WITH THE NUT DURING THE UNSCREWING, IT CAN SLIP AND CAUSE DAMAGE ON THE HEXAGON OF THE NUT, MAKING UNSCREWING IMPOSSIBLE. NOT RETURNED.

    Description of Event or Problem · 1

    THE SURGEON WANTED TO REMOVE THE SCREW AND ROD ON LEFT SIDE IN ORDER TO REINSERT SCREWS, BUT HE COULD NOT UNLOCK THE NUT. HE DECIDED TO STOP THE SURGERY AND TO OPERATE ON THE PATIENT FOUR DAYS LATER. THE NUT WAS PROBABLY DAMAGED BY INSTRUMENTS AND COULDN'T BE UNSCREWED, SO THE SURGEON HAD TO CUT THE CONNECTOR TO REMOVE THE SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94921 PASS MIS BREAK AWAY NUT WITH DOUBLE HEXAGON MNI MEDICREA INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization