BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON AGILE SPINAL SYSTEM

    MDR report key: 1356017 · Received February 12, 2009

    Report

    Report Number
    1030489-2009-00143
    Event Type
    Malfunction
    Date Received
    February 12, 2009
    Report Date
    January 13, 2009
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    NQP
    PMA / PMN Number
    K060615
    Removal / Correction Number
    1030489-122107-009-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE DEVICE OR APPLICABLE FILMS HAVE NOT BEEN RETURNED TO MEDTRONIC FOR EVALUATION. UNABLE TO DETERMINE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FOLLOW-UP X-RAY, THE PATIENT WAS FOUND TO HAVE A BROKEN POSTERIOR ROD. THE PATIENT IS ASYMPTOMATIC AND REPORTEDLY DOING VERY WELL. THE SURGEON WILL CONTINUE TO MONITOR AND THERE ARE NO PLANS FOR A REVISION SURGERY AT THIS TIME.

    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 UNK