BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON AGILE SPINAL SYSTEM

    MDR report key: 1082264 · Received July 24, 2008

    Report

    Report Number
    1030489-2008-00368
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    June 24, 2008
    Report Date
    June 25, 2008
    Manufacturer
    WARSAW ORTHOPAEDIC 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WERE RETURNED TO MEDTRONIC FOR EVALUATION. VISUAL EXAMINATION CONFIRMED EACH ROD HAD FAILURES OF THE CABLES THAT OCCURRED AT EACH ROD FLANGE. A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO DOCUMENTATION TO INDICATE A NON-CONFORMANCE TO SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT SURGERY FOR POSTERIOR FIXATION AT L3-4 WITH DYNAMIC RODS. SOMETIME POST-OP, X-RAYS REVEALED A ROD CABLE BREAKAGE. THE PT UNDERWENT A REVISION IN 2008 TO REMOVE THE CONSTRUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON AGILE SPINAL SYSTEM NQP WARSAW ORTHOPAEDIC INC. NA AT200610P105

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention