BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1456404 · Received June 18, 2009

    Report

    Report Number
    1030489-2009-00569
    Event Type
    Malfunction
    Date Received
    June 18, 2009
    Date of Event
    May 20, 2009
    Report Date
    May 20, 2009
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS, IN ADDITION, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A TLIF AT L4/5 USING POSTERIOR FIXATION AND INTERBODY DEVICE, IT WAS REPORTED THAT A BREAK OFF SET SCREW OF THE POSTERIOR FIXATION SYSTEM COULD NOT BE PROPERLY IMPLANTED AT RIGHT SIDE L4 AND L5. THE SURGEON BELIEVED THAT IT WAS BECAUSE THE PROPER INSTRUMENT TECHNIQUE WAS NOT USED TO IMPLANT THE ROD AND SET SCREW. NO OTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM SET SCREW KWP WARSAW ORTHOPEDIC INC. NA 0009988W

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR INTERBODY DEVICE