BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL FIXATION SYSTEM

    MDR report key: 2129996 · Received April 21, 2011

    Report

    Report Number
    3008524126-2011-00007
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    March 21, 2011
    Report Date
    April 6, 2011
    Manufacturer
    ORTHOFIX INC.
    Product Code
    MNI
    PMA / PMN Number
    K994217
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BASED ON INFO PROVIDED, THE SFS MULTI-AXIAL SCREW BROKE AND THE BODY OF THE SCREW WAS UNABLE TO BE REMOVED FROM THE PEDICLE BONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINAL FIXATION SYSTEM 5.5MM X 45MM MULTI-AXIAL SCREW SELF TAPP MNI ORTHOFIX INC. 58-3545 P12

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention