BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1473670 · Received August 6, 2009

    Report

    Report Number
    1030489-2009-00739
    Event Type
    Malfunction
    Date Received
    August 6, 2009
    Report Date
    July 10, 2009
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    UNK
    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 MFR FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. THE SUSPECT DEVICES IN USE ARE LOT # H08G59, W08D5016, OR W08F1446. IN ADDITION, THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 75446545, 510K # K042025 WAS CLEARED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD UNDERGONE A TLIF TO FIX L4/5 USING POSTERIOR FIXATION AND INTERBODY DEVICE CONCOMITANTLY. IT WAS REPORTED THAT THE CAGE BACKED OUT DUE TO LOOSENING OF PEDICLE SCREW AT L5. IT WAS REPORTED THAT THE PT'S BONE WAS VERY BRITTLE. THERE IS NO PLAN OF THE REVISION SURGERY AT THIS TIME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR CAGE AT L4/5