BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1242578 · Received November 21, 2008

    Report

    Report Number
    1030489-2008-00633
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 20, 2008
    Report Date
    October 31, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED TO THE MFR FOR EVALUATION. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NONE-CONFORMANCE TO SPECIFICATIONS. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. IN ADDITION, THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 75445540 WAS CLEARED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGERY AT T8-T12 USING POSTERIOR FIXATION. THE PATIENT STARTED COMPLAINING OF PAIN APPROXIMATELY SIX MONTHS POST OP. THE X-RAYS REVEALED BROKEN SCREWS AT T12. FUSION REPORTEDLY WAS NOT COMPLETED. THE REVISION SURGERY TO REPLACE IMPLANTS WAS PERFORMED APPROXIMATELY SEVEN MONTHS POST OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM BONE SCREW KWP WARSAW ORTHOPEDIC INC. NA W07A1895

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention