BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1472291 · Received June 11, 2009

    Report

    Report Number
    1030489-2009-00497
    Event Type
    Malfunction
    Date Received
    June 11, 2009
    Report Date
    April 30, 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). NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT, HOWEVER, THE SUSPECT DEVICES IN USE ARE LOT # W07B3020, W07M0593, W08A5441, W08A5442, AND W08A5460. DEVICE HISTORY RECORDS FOR THESE LOTS 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 FOR METASTATIC TUMOR USING POSTERIOR FIXATION. IT WAS REPORTED THAT THE BREAK OFF PLUG BACKED OUT AT L1 AND L2. THE PATIENT REPORTEDLY WAS ASYMPTOMATIC. THERE IS NO PLAN OF REVISION SURGERY 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 W08A5460

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR