BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL FIXATION SYSTEM

    MDR report key: 5085936 · Received September 17, 2015

    Report

    Report Number
    3008524126-2015-00030
    Event Type
    Malfunction
    Date Received
    September 17, 2015
    Report Date
    September 17, 2015
    Manufacturer
    ORTHOFIX INC
    Product Code
    NKB
    PMA / PMN Number
    K081684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT MADE AVAILABLE TO MANUFACTURE.

    Description of Event or Problem · 1

    INFORMATION PROVIDED STATES THE REP HAD PREVIOUS ISSUES WITH THE PRESSURE CAP BECOMING UNSEATED ON TWO SFS SCREWS WHILE BEING IMPLANTED. REP STATED THAT THIS OCCURRED DURING TWO DIFFERENT SURGERIES. NO OTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617110 SPINAL FIXATION SYSTEM SFS SCREWS NKB ORTHOFIX INC

    Patients

    Seq Age Sex Outcome Treatment
    1