BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3881954 · Received June 18, 2014

    Report

    Report Number
    1030489-2014-02786
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    April 29, 2014
    Report Date
    May 21, 2014
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    K052187
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OF THE SIX SET SCREWS RETURNED THERE ARE TWO DISTINCT LOOKS. TWO OF THE SCREW SHOW TWO WITNESS MARKS ON EACH SIDE OF THE NODE WITH A ¿U CHANNEL¿ SHAPE DEFORMATION TO THE NODE ITSELF. THE OTHER FOUR SCREWS HAVE WITNESS MARK ON THE OUTER EDGE OF THE SET SCREW FACE AND THE NODE IS DEFORMED MORE IN A FLAT MANNER. THIS IS TYPICAL OF THE ROD NOT BEING FULLY SEATED IN THE BONE BEFORE THE SET SCREW WAS TORQUED DOWN. SOME OF THE SET SCREWS SHOW SIGNS OF HEAVY LOAD ON THE THREAD BUT NONE OF STRIPPED OUT.

    Additional Manufacturer Narrative · 1

    (B)(4): 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 POSTERIOR SPINAL SURGICAL PROCEDURE. IT WAS REPORTED THAT 11 MONTHS POST-OP IT WAS FOUND THAT THE SET SCREW AND THE ROD HAD MIGRATED. THE PATIENT UNDERWENT A REVISION SURGERY AND SIX SET SCREWS AND THE ROD WERE REMOVED AND REPLACED. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357259 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H13A3639

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR RODS, BONE SCREW