BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOENIX SFS SYSTEM

    MDR report key: 5580998 · Received April 15, 2016

    Report

    Report Number
    3008524126-2016-00009
    Event Type
    Malfunction
    Date Received
    April 15, 2016
    Date of Event
    March 18, 2016
    Report Date
    April 15, 2016
    Manufacturer
    ORTHOFIX INC
    Product Code
    NKB
    UDI-DI
    18257200028474
    PMA / PMN Number
    K122901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    INFORMATION PROVIDED STATES THAT DURING A CASE ONE OF THE PRONGS BROKE ON THE UNIVERSAL TAB REMOVER. THIS DELAYED THE CASE AND THE PRONG REMAINS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237821 PHOENIX SFS SYSTEM UNIVERSAL TAB REMOVAL HOOK NKB ORTHOFIX INC 20-0280 36680-PD09 18257200028474

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR