BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL FIXATION SYSTEM

    MDR report key: 2445506 · Received February 6, 2012

    Report

    Report Number
    3008524126-2012-00004
    Event Type
    Malfunction
    Date Received
    February 6, 2012
    Date of Event
    January 6, 2012
    Report Date
    February 6, 2012
    Manufacturer
    ORTHOFIX INC.
    Product Code
    MNI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BASED ON THE INFORMATION PROVIDED, THE 8.5MM SCREW WAS DETACHED FROM THE TULIP. THE TULIP WAS EXPLANTED AND THE SCREW REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINAL FIXATION SYSTEM 8.5MM X 80MM MULTI-AXIAL SCREW MNI ORTHOFIX INC. 56-3880 R01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other