BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1932281 · Received December 17, 2010

    Report

    Report Number
    1030489-2010-01606
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 26, 2010
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    KWP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 7540000, 510K # K031655 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 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 TLIF USING INTERBODY DEVICE AND POSTERIOR FIXATION AT L4-L5. THE RIGHT L5 SET SCREW CAME OFF POST OP. THE PATIENT ALSO DEVELOPED PSEUDOARTHROSIS AND COMPLAINED OF PAIN. THE REVISION SURGERY WAS PERFORMED APPROXIMATELY TWO YEARS POST OP. THE WHOLE CONSTRUCT WAS REMOVED AND REPLACED.

    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 W08H3141

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 Required Intervention