BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIREBIRD SPINAL FIXATION SYSTEM

    MDR report key: 2962075 · Received January 22, 2013

    Report

    Report Number
    3008524126-2013-00002
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    June 25, 2012
    Report Date
    January 22, 2013
    Manufacturer
    ORTHOFIX INC.
    Product Code
    NKB
    PMA / PMN Number
    K081684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BASED ON INFORMATION PROVIDED TWO OF THE SET SCREWS LOOSENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31551 FIREBIRD SPINAL FIXATION SYSTEM SET SCREW NKB ORTHOFIX INC. 44-2001 (X2)

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other