BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 3546571 · Received January 2, 2014

    Report

    Report Number
    1030489-2014-00004
    Event Type
    Injury
    Date Received
    January 2, 2014
    Date of Event
    November 25, 2013
    Report Date
    December 4, 2013
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 5442147, 510K # K091974 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L1-5. ONE WEEK POST-OP IT WAS FOUND THAT THE BREAK OFF PORTION OF THE SET SCREW WAS LEFT ABOVE L3. PER THE PATIENT¿S REQUEST, A SURGERY TOOK PLACE TO REMOVE THE FRAGMENT. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2128 CD HORIZON SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB WARSAW ORTHOPEDICS 0272622W

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention