BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON AGILE SPINAL SYSTEM

    MDR report key: 1080209 · Received July 22, 2008

    Report

    Report Number
    1030489-2008-00356
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    May 29, 2008
    Report Date
    June 18, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    NQP
    PMA / PMN Number
    K060615
    Removal / Correction Number
    1030489-122107-009-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE EXPLANTED PORTION OF THE DEVICES WAS DISCARDED BY THE HOSPITAL; THEREFORE, NO PRODUCT IS AVAILABLE TO RETURN FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT L3-S1 FUSION WITH POSTERIOR DYNAMIC ROD FIXATION AT L2-S1 AND INTERBODY DEVICES. POST-OP X-RAYS TAKEN IN 2008 SHOWED A BROKEN CABLE ON ONE SIDE OF THE CONSTRUCT. THE PT UNDERWENT REVISION ON THE FOLLOWING MONTH, TO REMOVE HARDWARE ONLY AT L2 ON EACH SIDE. THE UPPER PORTION OF THE RODS INCLUDING THE BUMPER AND CABLES WERE REMOVED ALONG WITH THE SETSCREWS AND BONE SCREWS. ORIGINAL HARDWARE AT L3-S1 WAS LEFT IMPLANTED. IT WAS REPORTED THAT FUSION WAS COMPLETE AND THE PT IS DOING GREAT FOLLOWING THE REVISION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention