BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON LEGACY 5.5 ROD

    MDR report key: 3242322 · Received July 8, 2013

    Report

    Report Number
    3242322
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 28, 2013
    Report Date
    June 29, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    ANTERIOR SPINAL ROD REMOVED DUE TO BEING BROKEN. THE EYEBOLTS, RODS, SCREWS AND STAPLES WERE REMOVED AT T12, L1, L2 AND L3. THESE WERE 4 EYEBOLTS, 4 SCREWS, AND 4 STAPLES, AND 2 RODS AS THE ROD WAS BROKEN.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?THERAPY FOR IDIOPATHIC SCOLIOSIS AND A LUMBAR CURVE.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310849 CD HORIZON LEGACY 5.5 ROD APPLIANCE, FIXATION, ROD NKB MEDTRONIC SOFAMOR DANEK * *

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR