BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON AGILE SPINAL SYSTEM

    MDR report key: 1353348 · Received March 19, 2009

    Report

    Report Number
    1030489-2009-00258
    Event Type
    Injury
    Date Received
    March 19, 2009
    Date of Event
    February 19, 2009
    Report Date
    February 17, 2009
    Manufacturer
    MEDTRONIC ORTHOPEDIC INC.
    Product Code
    NQP
    PMA / PMN Number
    K060615
    Removal / Correction Number
    Z14152008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO MEDTRONIC FOR EVALUATION. A REVIEW OF X-RAY FILMS TAKEN PRIOR TO REVISION SURGERY VERIFIED BILATERAL FRACTURE OF CONSTRUCT. VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE CABLE FRACTURED AT THE DISTAL END BY THE FLANGE. THE CABLE OF THE OTHER ROD FRACTURED NEAR THE CENTER OF THE TWO FLANGES. THE CABLE WITH THE PLUG CAME OFF AT THE PROXIMAL END OF BOTH RODS. BOTH BUMPERS AND RODS WERE IN GOOD CONDITION. 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 PATIENT UNDERWENT SURGERY FOR IMPLANT AT L3-L5 WITH THE DYNAMIC SEGMENT AT L3-L4. THE PATIENT'S ROD BROKE POST-OP (DATE OF BREAKAGE UNKNOWN). REVISION SURGERY WAS PERFORMED TO REMOVE THE IMPLANTED SYSTEM AND EXTEND FUSION TO L2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON AGILE SPINAL SYSTEM NQP MEDTRONIC ORTHOPEDIC INC. NA AT200610P050

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention