BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1960901 · Received January 14, 2011

    Report

    Report Number
    1030489-2011-00041
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 17, 2010
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    PMA / PMN Number
    K042025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    THE SCREW WAS RETURNED FOR EVALUATION. MACROSCOPIC AND OPTICAL EXAMINATION OF THE SET SCREW REVEALED THE THREAD CRESTS AND FLANKS ARE DAMAGED; THIS DAMAGE APPEARS TO HAVE INITIATED AT THE START OF THE THREAD, CONSISTENT WITH SET SCREW MISUSE DUE TO MISALIGNMENT OF THE FAS HEAD AND SET SCREW THREADS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A POSTERIOR SPINAL FUSION AT T11- L2. IT WAS REPORTED THAT THE SET SCREW STRIPPED WHILE BEING TIGHTENED IN THE BONE SCREW. THE SET SCREW AND BONE SCREW WERE REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDIC, INC. NA 0117648W

    Patients

    Seq Age Sex Outcome Treatment
    1 BONE SCREW