BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3190332 · Received June 26, 2013

    Report

    Report Number
    1030489-2013-02528
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    May 28, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. HOWEVER, THE SUSPECT DEVICES IN USE ARE PART # G8699060 AND LOT # 0151737W; PART # 4200822INT, LOT H13B2790; PART # 5530230, LOT 0243051W; PART # 55790016545, LOT 0247138W; PART # 55790017550, LOT 0244609W; PART # 8670001, LOT SW12J281. (B)(4): MANUFACTURE DATE FOR LOT 0151737W IS 03-30-11; MANUFACTURE DATE FOR LOT H13B2790 IS 03/27/13; MANUFACTURE DATE FOR LOT 0243051W IS 12/12/12; MANUFACTURE DATE FOR LOT 0247138W IS 01/04/13; MANUFACTURE DATE FOR LOT 0244609W IS 12/12/12; MANUFACTURE DATE FOR LOT SW12J281 IS 02/12/13. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL SURGICAL PROCEDURE TO TREAT LUMBAR CANAL STENOSIS. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO POST-OPERATIVE INFECTION. NO ADDITIONAL INFO WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289923 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MEDTRONIC SOFAMOR DANEK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention RODS, SCREWS, VB REPLACEMENT