BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIREBIRD SPINAL FIXATION SYSTEM

    MDR report key: 2455938 · Received February 1, 2012

    Report

    Report Number
    3008524126-2012-00001
    Event Type
    Malfunction
    Date Received
    February 1, 2012
    Date of Event
    December 30, 2011
    Report Date
    January 30, 2012
    Manufacturer
    ORTHOFIX INC.
    Product Code
    NKB
    PMA / PMN Number
    K093926
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BASED ON INFO PROVIDED, THE SET SCREWS BACKED OUT AND THE CONSTRUCT LOOSENED. THE PRODUCT WAS REPLACED AND PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIREBIRD SPINAL FIXATION SYSTEM FIREBIRD SPINAL FIXATION SYSTEM NKB ORTHOFIX INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other