BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON AGILE SPINAL SYSTEM

    MDR report key: 1062934 · Received June 19, 2008

    Report

    Report Number
    1030489-2008-00286
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    May 20, 2008
    Report Date
    May 20, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TWO RODS, SIX BONE SCREWS, AND SIX SETSCREWS WERE RETURNED TO MEDTRONIC FOR EVAL. ONE OF THE RODS HAD A FRACTURED CABLE. FAILURE OF THE FIBERS OCCURRED AT THE ROD FLANGE. A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO DOCUMENTATION TO INDICATE A NON-CONFORMANCE TO SPEC.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A TLIF AT L4-5 WITH POSTERIOR DYNAMIC ROD FIXATION AT L3-5. IT WAS REPORTED THAT THE PT WAS EXPERIENCING PAIN AND UNDERWENT ADDITIONAL SURGERY TO REMOVE THE HARDWARE. DURING THE REMOVAL, IT WAS NOTICED THAT THE RIGHT SIDED ROD WAS FRACTURED. IT WAS REPORTED THAT FUSION WAS COMPLETE AND NO ADDITIONAL HARDWARE WAS IMPLANTED. NO PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON AGILE SPINAL SYSTEM NQP WARSAW ORTHOPEDIC INC. NA AT2007011032

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention