BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLANTIS, FIXED SCREWS

    MDR report key: 3042069 · Received April 5, 2013

    Report

    Report Number
    3042069
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 5, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    KWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RADIOGRAPHIC IMAGING CONFIRMED A FRACTURED INTERBODY SCREW.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?C5/6 DISCECTOMY & FUSION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141262 ATLANTIS, FIXED SCREWS APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MEDTRONIC SOFAMOR DANEK USA, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR ALSO| ONE OF THE SCREWS THAT WAS IMPLANTED IN 2001 BROKE| REQUIRING THE PLATE AND OTHER SCREWS TO BE REMOVED