BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2287499 · Received October 12, 2011

    Report

    Report Number
    1030489-2011-01308
    Event Type
    Injury
    Date Received
    October 12, 2011
    Date of Event
    September 12, 2011
    Report Date
    September 12, 2011
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    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 # 8670855, 510K # K000453 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. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L4-5. IT WAS REPORTED THAT ONE OF THE NUTS WAS NOT ABLE TO BREAK OFF. THE SURGEON TRIED TO BREAK OFF AFTER ADDING INCISION TO HOLD A SCREW HEAD WITH PLIERS AND REPLACED THE NUT WITH A NEW NUT, BUT HE WAS NOT ABLE TO BREAK OFF THE NUT AGAIN. THE SURGEON OPTED NOT TO BREAK OFF THE NUT BECAUSE THE NUT HAD SECURELY FASTENED, AND THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS NA 0165989W

    Patients

    Seq Age Sex Outcome Treatment
    1 SCREW