BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1757244 · Received June 18, 2010

    Report

    Report Number
    1030489-2010-00824
    Event Type
    Malfunction
    Date Received
    June 18, 2010
    Date of Event
    May 26, 2010
    Report Date
    May 26, 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): THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG #8670855, 510K # K000453 WAS CLEARED IN THE UNITED STATES. DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE 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 SURGEON HAD DIFFICULTY IN IMPLANTING SET SCREWS AT BOTH SIDES L4 DURING A POSTERIOR FIXATION PROCEDURE AT L4-L5, BECAUSE THE SET SCREWS WERE CROSS THREADED. ONE SIDE SET SCREW WAS REPLACED TO A NEW ONE. BOTH PEDICLE SCREW AND SET SCREW WERE REPLACED ON THE OTHER SIDE. THE PROCEDURE WAS COMPLETED WITHOUT ADDITIONAL COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM SET SCREW NKB WARSAW ORTHOPEDIC INC. NA 0073479W

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR ROD| IMPLANTED:| PEDICLE SCREW:| IMPLANTED: