BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1749270 · Received July 2, 2010

    Report

    Report Number
    1030489-2010-00876
    Event Type
    Malfunction
    Date Received
    July 2, 2010
    Report Date
    June 7, 2010
    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). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 869-021, 510K # K040962 WAS CLEARED IN THE UNITED STATES. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVAL. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. DEVICE HISTORY RECORDS FOR THIS LOT WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A SPINAL PROCEDURE TO IMPLANT THE POSTERIOR FIXATING AT T9 TO L3. THE X-RAYS SHOWED ROD BREAKAGE POST OP. FUSION FAILURE IS SUSPECTED. THE REVISION SURGERY MIGHT BE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM ROD KWP WARSAW ORTHOPEDIC INC. NA 0003127W

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR IMPLANTED:| IMPLANTED:| SET SCREWS| PEDICLE SCREWS