BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1471482 · Received June 4, 2009

    Report

    Report Number
    1030489-2009-00515
    Event Type
    Malfunction
    Date Received
    June 4, 2009
    Date of Event
    May 8, 2009
    Report Date
    May 8, 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). PRODUCT REMAINS IMPLANTED, PRODUCT RETURN IS NOT POSSIBLE. THE FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION EITHER. 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 # 7540000, 510K #K031655 WAS CLEARED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL PROCEDURE TO IMPLANT POSTERIOR FIXATION AT L2/3. ONE OF THE BREAK-OFF PLUGS REPORTEDLY BACKED OUT POST OP. THE PATIENT WAS SYMPTOMATIC. NO REVISION SURGERY IS PLANNED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM SET SCREW KWP WARSAW ORTHOPEDIC INC. NA W08G4331

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR