BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON LEGACY

    MDR report key: 3242182 · Received July 8, 2013

    Report

    Report Number
    3242182
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 30, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD, IN THE WINTER OF 2011, EXTENSION OF HER FUSION TO T9 WITH EXCISION OF PSEUDOARTHROSIS AND ROD REPLACEMENT, T10-S1 DUE TO A FRACTURED ROD. THE PATIENT HAD BEEN DOING WELL, AND BACK PAIN WAS IMPROVING UNTIL THE SUMMER OF 2012. THERE WAS NO INJURY. SHE STARTED HAVING INCREASED PAIN. SHE CAME IN AND WAS FOUND TO HAVE ANOTHER FRACTURE OF HER ROD AGAIN AND WITH SUSPICION FOR PSEUDOARTHROSIS. SHE CURRENTLY REPORTS PAIN IN THE MID TO LOWER BACK RADIATING DOWN TOWARDS HER BUTTOCKS.PATH REPORT ON EXPLANT: A SEPARATE, 0.9 CM LENGTH, 0.6 CM DIAMETER, IRREGULAR, CYLINDRICAL PORTION OF SILVER SURGICAL METAL HARDWARE THAT APPEARS BROKEN AT ONE EDGE IS PRESENT (PARTIAL INTACT SERIAL NUMBER: "X03100/020900").WHAT WAS THE ORIGINAL INTENDED PROCEDURE?SPINAL STABILIZATION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310922 CD HORIZON LEGACY APPLIANCE, FIXATION, ROD KWP MEDTRONIC SOFAMOR DANEK USA, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR