BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1785587 · Received July 30, 2010

    Report

    Report Number
    1030489-2010-01008
    Event Type
    Injury
    Date Received
    July 30, 2010
    Report Date
    July 9, 2010
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    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 EVALUATION. 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: IT WAS FOUND THAT THE RODS BROKE ON BOTH SIDES L3-L4 APPROXIMATELY 10 MONTHS IMPLANTATION. FUSION REPORTEDLY FAILED. REVISION SURGERY IS NOT SCHEDULED AT THIS TIME. IT IS BELIEVED THAT THE SKIPPED LEVEL OF L1, L2 AND L3 MIGHT BE A CAUSE OF THE ROD BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM ROD KWQ WARSAW ORTHOPEDIC INC. NA 0025644W

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention