BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIREBIRD/PHOENIX MIS

    MDR report key: 2142647 · Received May 19, 2011

    Report

    Report Number
    3008524126-2011-00011
    Event Type
    Malfunction
    Date Received
    May 19, 2011
    Date of Event
    April 11, 2011
    Report Date
    May 18, 2011
    Manufacturer
    ORTHOFIX INC.
    Product Code
    NKB
    PMA / PMN Number
    K081684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BASED ON THE INFORMATION PROVIDED, THE ROD BROKE FREE FROM THE PHOENIX ROD INSERTER IN-VIVO. THE SURGERY WAS EXTENDED BY 45 MINUTES. A BACK-UP PROVIEW INSERTER WAS USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIREBIRD/PHOENIX MIS PHOENIX ROD HOLDER/INSERTER NKB ORTHOFIX INC. 20-0214 32586-NC07

    Patients

    Seq Age Sex Outcome Treatment
    1 Other