BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1561860 · Received December 16, 2009

    Report

    Report Number
    1030489-2009-01176
    Event Type
    Injury
    Date Received
    December 16, 2009
    Date of Event
    November 20, 2009
    Report Date
    November 20, 2009
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. EXPLANTED DEVICES WERE NOT RETURNED TO THE MFR FOR EVAL. BASED ON VISUAL REVIEW OF THE PICTURES SUBMITTED AND EVENT INFO, THE IMPLANTED ROD APPEARS TO HAVE BEEN IMPROPERLY PLACED WITH RESPECT TO THE MA SCREWS. THIS MAY HAVE CONTRIBUTED TO IMPROPER SET SCREW LOCATION, AND ASSOCIATED INSUFFICIENT ROD FIXATION. THE OBSERVATIONS ARE CONSISTENT WITH IMPROPER TECHNIQUE, CONTRIBUTING TO THE FOREGOING EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A TLIF BY MIS AT L4/5 USING INTERBODY DEVICES AND POSTERIOR FIXATION. IT WAS REPORTED THAT THE PT UNDERWENT REVISION SURGERY DUE TO FUSION FAILURE CONSIDERED RESULTED FROM THE LOOSENED SCREW AT RIGHT L4. IT WAS CONFIRMED AT REVISION SURGERY THAT THE SET SCREW WAS LOOSENED AND FUSION FAILED AT THE SURGICAL SITE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention FIXATION ROD., CATALOG # G8673035.