BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIREBIRD SFS

    MDR report key: 7527739 · Received May 18, 2018

    Report

    Report Number
    2183449-2018-00012
    Event Type
    Malfunction
    Date Received
    May 18, 2018
    Report Date
    May 14, 2018
    Manufacturer
    ORTHOFIX INC.
    Product Code
    KWP
    UDI-DI
    18257200014453
    PMA / PMN Number
    K092624
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION PROVIDED STATES THAT APPROXIMATELY 3 WEEKS POST OP IT WAS NOTICED THAT THE 450MM ROD HAD BROKEN. THE PATIENT IS ASYMPTOMATIC AND A REVISION HAS NOT BEEN PLANNED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367984 FIREBIRD SFS ROD, 450MM X DIA 5.5MM, COCR KWP ORTHOFIX INC. 51-2450 18257200014453

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other