BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 4062839 · Received September 5, 2014

    Report

    Report Number
    1030489-2014-03638
    Event Type
    Injury
    Date Received
    September 5, 2014
    Date of Event
    August 15, 2014
    Report Date
    August 15, 2014
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 5440430, 510K # K102555 WAS CLEARED IN THE UNITED STATES. 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

    MACROSCOPIC AND OPTICAL EXAMINATION REVEALED MINOR THREAD CREST AND FLANK DAMAGE. THE SCREW WOULD STILL ENGAGE IN A SAMPLE MAS SCREW. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH MISALIGNMENT OF THE MAS AND SET SCREW THREADS DURING CONSTRUCT ASSEMBLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRANSFORAMINAL LUMBER INTERBODY FUSION AT L4-5. IT WAS REPORTED THAT THE SET SCREW STRIPPED DURING INSERTION AT THE LEFT L5 BONE SCREW. THE EXTENDER WAS REMOVED AND THE SCREW WAS REMOVED AND REPLACED WHICH WAS SUCCESSFULLY BROKEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546024 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP MDT SOFAMOR DANEK PUERTO RICO MFG NA H13J0855

    Patients

    Seq Age Sex Outcome Treatment
    1 BONE SCREW