BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1294915 · Received January 20, 2009

    Report

    Report Number
    1030489-2009-00051
    Event Type
    Injury
    Date Received
    January 20, 2009
    Date of Event
    December 26, 2008
    Report Date
    December 22, 2008
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT; HOWEVER, THE SUSPECT DEVICES IN USE ARE LOT# W05B0983 AND #W07H1288. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. IN ADDITION, THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 855-012, WAS CLEARED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PLIF AT L1-S1 USING POSTERIOR FIXATION. THE PATIENT COMPLAINED OF PAIN IN ARTICULATION COXAE AT UNKNOWN TIME POST OP. IT WAS FOUND BY X-RAY THAT A ROD AT L4/5 WAS BROKEN. THE REVISION SURGERY WAS PERFORMED TO REMOVE THE CONSTRUCT APPROXIMATELY 8 MONTHS POST OP. AT THE REMOVAL PROCEDURE, IT WAS NOTICED THAT FUSION OCCURRED. IT WAS REPORTED THAT "THE SURGEON COMMENTED THAT THE CAUSE OF PAIN IN ARTICULATION COXAE WAS NOT CONCERNED WITH THE BROKEN ROD".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention