BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1502404 · Received October 8, 2009

    Report

    Report Number
    1030489-2009-00916
    Event Type
    Injury
    Date Received
    October 8, 2009
    Date of Event
    June 1, 2009
    Report Date
    September 10, 2009
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    NKB
    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

    THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE THE MFR CANNOT DETERMINE THE SUSPECT DEVICE. FOR FURTHER DETAILS ABOUT THE SCREWS ASSOCIATED WITH THIS EVENT. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. 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. MFR DATE FOR LOT W08E0313 IS 05/16/2008; MFR DATE FOR LOT W08E1547 IS 06/04/2008; MFR DATE FOR LOT W08E1548 IS 06/02/2008; MFR DATE FOR LOT W08E2318 IS 06/09/2008. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A PLIF AT L4/5 TO IMPLANT TWO INTERBODY DEVICES AND POSTERIOR FIXATION. IT WAS REPORTED THAT THE PLUG AT RIGHT L5 BACKED OUT APPROX. 10 MONTHS POST OP. THE REVISION SURGERY WAS PERFORMED IN 2009, TO REPLACE ALL FOUR SCREWS. "THE SURGEON STATED THAT THE PLUG BACKED OUT BECAUSE OF THE PT'S BAMBOO SPINE DEPRIVED OF ANY FLEXIBILITY ALONG WITH EXTREMELY HARDENED LIGAMENT, WHICH BROUGHT ABOUT TOO MUCH BURDEN ON THE IMPLANTS AT THE FIXATION AREA POSTOPERATIVELY."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention LOT# W08E2318| PART # G7540000: LOT# W08E0313| LOT# W08E1547| LOT# W08E1548