BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIREBIRD SPINAL FIXATION SYSTEM, PHEONIX MIS

    MDR report key: 3963703 · Received June 18, 2014

    Report

    Report Number
    3008524126-2014-00015
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    January 1, 2012
    Report Date
    May 19, 2014
    Manufacturer
    ORTHOFIX INC.
    Product Code
    NKB
    PMA / PMN Number
    K122901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BASED ON THE INFORMATION PROVIDED, THE 44-2001 SET SCREW BACKED OUT. THE PRODUCT WAS REPLACED AND THE PATIENT IS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356695 FIREBIRD SPINAL FIXATION SYSTEM, PHEONIX MIS SET SCREW NKB ORTHOFIX INC. 44-2001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other