BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FIREBIRD SPINAL FIXATION

    MDR report key: 3173479 · Received June 11, 2013

    Report

    Report Number
    3008524126-2013-00019
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    April 15, 2013
    Report Date
    June 11, 2013
    Manufacturer
    ORTHOFIX INC.
    Product Code
    NKB
    PMA / PMN Number
    K081684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    BASED ON THE INFO PROVIDED, THE 52-2450 ROD ON THE RIGHT SIDE OF THE SPINE BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264801 FIREBIRD SPINAL FIXATION 450MM ROD NKB ORTHOFIX INC. 52-2450

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other