BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3850766 · Received June 5, 2014

    Report

    Report Number
    1030489-2014-02711
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 6, 2014
    Report Date
    May 7, 2014
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    K042025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO: VISUAL REVIEW CONFIRMS SCREW BREAKAGE APPROXIMATELY ~2-3 THREADS FROM BONE SCREW HEAD. OPTICAL EXAMINATION OF ADJACENT SURFACES AROUND THE AREA OF CRACK PROPAGATION DID NOT IDENTIFY MATERIAL SURFACE DEFECT THAT COULD CONTRIBUTE TO CRACK PROPAGATION. SIGNIFICANT DAMAGE AND/OR SMEARING NOTED TO ALL FRACTURE SURFACES. THE LOWER BROKEN PORTION OF THE BONE SCREW IS CONSISTENT WITH EXPLANTATION. FRACTURE SURFACE EXAMINATION IDENTIFIED A MULTI-MODAL FRACTURE, WITH PROGRESSIVE STRIATIONS EMANATING AWAY FROM THE ORIGIN OF INITIAL FRACTURE PROPAGATION AS NOTED, AS WELL AS INCREASED MATERIAL DISRUPTION, RIVER LINES, AND SHEAR LIPS, STARTING APPROXIMATELY ~50% OF THE WAY THROUGH THE CROSS-SECTIONAL AREA OF THE BONE SCREW, CONSISTENT WITH OVERLOAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A THREE LEVEL POSTERIOR LUMBAR FUSION. IT WAS REPORTED THAT THE SCREW BROKE IN HALF ABOUT 5MM BELOW THE TULIP HEAD. THE PATIENT UNDERWENT A REVISION SURGERY TO EXTEND THE CONSTRUCT DUE TO NON-UNION. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330180 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H12V0943

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ROD, SET SCREW,