BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2881194 · Received December 20, 2012

    Report

    Report Number
    1030489-2012-02903
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 26, 2012
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    PMA / PMN Number
    K981676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MACROSCOPIC AND OPTICAL EXAMINATION REVEALED THREAD CREST AND FLANK DAMAGE; THIS DAMAGE APPEARS TO HAVE INITIATED AT THE START OF THE THREAD, AND IS CONSISTENT AROUND THE DAMAGED PORTION OF THE THREAD. FUNCTIONAL EVALUATION WITH A SAMPLE MAS FOUND THE SET SCREW UNABLE TO BE ENGAGED IN THE MAS HEAD. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH MISALIGNMENT OF THE MAS AND SET SCREW THREADS DURING CONSTRUCT ASSEMBLY.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SETSCREWS 'SLID' DURING INSERTION INTO THE BONE SCREW. THE SCREWS 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 MDT SOFAMOR DANEK PUERTO RICO MFG NA H12C0157

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR BONE SCREW