BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1437821 · Received April 23, 2009

    Report

    Report Number
    1030489-2009-00386
    Event Type
    Malfunction
    Date Received
    April 23, 2009
    Date of Event
    March 17, 2009
    Report Date
    March 26, 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). DEVICE WAS NOT RETURNED TO MFR FOR EVAL. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT; HOWEVER, THE SUSPECT DEVICES IN USE ARE LOT# W08A5509 AND W08B0917. 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 US; HOWEVER A LIKE DEVICE CATALOG # 8590855, 501K # K981676 WAS CLEARED IN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A SPINAL PROCEDURE FOR STENOSIS AT L1/2 USING POSTERIOR FIXATION. THE SURGEON CONFIRMED THAT A BREAK OFF SET SCREW CAME OFF AT L1 BY X-RAY. THE PT REPORTEDLY WAS WALKING AROUND NOT WEARING A CORSET AFTER THE SURGERY. THERE IS NO PLANS OF REVISION SURGERY AT THIS TIME. THE SURGEON IS MONITORING THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM SET SCREW KWP WARSAW ORTHOPEDIC INC NA W08A5509

    Patients

    Seq Age Sex Outcome Treatment
    1