BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1547685 · Received November 18, 2009

    Report

    Report Number
    1030489-2009-01078
    Event Type
    Malfunction
    Date Received
    November 18, 2009
    Date of Event
    August 11, 2009
    Report Date
    August 11, 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

    (B) (4): THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 8590855, 510K # K981676 WAS CLEARED IN THE UNITED STATES. THE IMPLANT REMAINS IMPLANTED, PRODUCT EVAL IS NOT POSSIBLE AT THIS TIME. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO FUSE T12-L3 USING POSTERIOR FIXATION, SEVERAL BREAK-OFF SET SCREWS COULD NOT BE BROKEN OFF. THE SURGEON TWISTED OFF THE TAB OF THE BREAK-OFF SET SCREWS OUTSIDE OF THE OPERATIVE SITE AND IMPLANTED THEM BACK. 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 0002214W

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR