BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1785579 · Received July 30, 2010

    Report

    Report Number
    1030489-2010-01012
    Event Type
    Malfunction
    Date Received
    July 30, 2010
    Date of Event
    July 8, 2010
    Report Date
    July 8, 2010
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    NKB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG #8670855, 510K #K000453 WAS CLEARED IN THE UNITED STATES. THE DEVICES WERE NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A REVIEW OF DEVICE HISTORY RECORDS IS NOT POSSIBLE AT THIS TIME WITHOUT ADDITIONAL DEVICE INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PLIF TO FUSE L4-5 USING MIN - INVASIVE PROCEDURE. IT WAS REPORTED THAT THE PLUGS IN THE LEFT SIDE COULD NOT BE BROKEN OFF. PEDICLE SCREWS ON BOTH CRANIAL AND CAUDAL WERE REPLACED TO NEW ONES, AND THE PLUGS WERE TRIED AGAIN FOR THE SAME RESULT. SO, THE PEDICLE SCREW ON CRANIAL AND THE INNER SLEEVE OF THE EXTENDER WERE REPLACED. BY THIS REPLACEMENT, THE PLUGS COULD FINALLY BE BROKEN OFF.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 PEDICLE SCREWS| IMPLANTED: