BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1457462 · Received June 25, 2009

    Report

    Report Number
    1030489-2009-00587
    Event Type
    Malfunction
    Date Received
    June 25, 2009
    Date of Event
    May 26, 2009
    Report Date
    May 28, 2009
    Manufacturer
    WARSAW ORTHOPAEDIC 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. IN ADDITION, THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 7540120, 510K# K052187 WAS CLEARED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PLF. THE LAMINA HOOKS WERE IMPLANTED AT L4. IT WAS FOUND THAT A NON-BREAK OFF PLUG CAME OFF FROM THE HOOK AT RIGHT SIDE. 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 ORTHOPAEDIC INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1