BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3022968 · Received March 27, 2013

    Report

    Report Number
    1030489-2013-00865
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OPTICAL EXAMINATION OF THE THREADS IDENTIFIED ATYPICAL WEAR ON THE UPPER FLANKS OF THE THREAD, WHICH IS INCONSISTENT WITH NORMAL TIGHTENING. ADDITIONAL EXAMINATION IDENTIFIED DEFORMATION ON THE LOWER PORTION OF THE FLANK AT A SPECIFIC LOCATION, WITH VERY LITTLE INTERFACE ON THE ENTIRE ROD INTERFACE SURFACE. THIS SUGGESTS INTERFERENCE OF SOME ADDITIONAL PORTION OF THE CONSTRUCT. FUNCTIONAL EVALUATION WITH A SAMPLE LEGACY MAS FOUND THE RETURNED SET SCREW ABLE TO BE FULLY ENGAGED INTO THE MAS HEAD. AFTER VISUAL, OPTICAL AND FUNCTIONAL EVALUATION, NO EVIDENCE WAS FOUND THAT WOULD SUGGEST A DEFECT IN MANUFACTURING OR PROCESSING OF THE IMPLANT OR ASSOCIATED COMPONENTS. THE IMPLANT APPEARS TO BE CAPABLE OF PERFORMING ITS INTENDED FUNCTION.

    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 LUMBAR SURGICAL PROCEDURE AT L3-5 TO TREAT LUMBAR SPINAL CANAL STENOSIS. IT WAS REPORTED THAT THE SET SCREW CROSS THREADED DURING PLACEMENT IN THE BONE SCREW. THE SCREW WAS REMOVED AND REPLACED. IT WAS ALSO REPORTED THAT DURING THE SURGERY THE PATIENT MAY HAVE SUFFERED AN UNINTENDED DUROTOMY. THIS COULD NOT BE CONFIRMED BUT THE SURGEON SUTURED AROUND THE MIDLINE DURING DECOMPRESSION. NO OTHER COMPLICATIONS WERE REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127210 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H12F2769

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Required Intervention