BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 2248448 · Received September 14, 2011

    Report

    Report Number
    1030489-2011-01157
    Event Type
    Injury
    Date Received
    September 14, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 17, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. THE LOTS THAT WERE USED ARE PART# G869H021; LOT W08C0106, EXPIRATION DATE 2013-03-12; LOT W08C1719, EXPIRATION DATE 2013-03-31. THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 869-021, 510K # K040962 WAS CLEARED IN THE UNITED STATES. THE MANUFACTURE DATE FOR LOT W08C0106 IS 2008-03-03; THE MANUFACTURE DATE FOR LOT W08C1719 IS 2008-03-14. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. DEVICE HISTORY RECORDS FOR THESE LOTS 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 PATIENT UNDERWENT A PEDICLE SUBTRACTION OSTEOTOMY DUE TO KYPHOSIS FROM T4- ILIAC. IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY 30 MONTHS POST-OP DUE TO ROD BREAKAGE AT THE L4-5 AREA. THE ROD WAS REMOVED AND REPLACED WITH A NEW ROD AS WELL AS A NEW VB REPLACEMENT DUE TO NON-UNION AT THAT LEVEL. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDIC, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCREWS, VB REPLACEMENT