BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON AGILE SPINAL SYSTEM

    MDR report key: 1181772 · Received September 18, 2008

    Report

    Report Number
    1030489-2008-00532
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Report Date
    August 20, 2008
    Manufacturer
    MEDTRONIC 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO MEDTRONIC FOR EVALUATION. UNABLE TO DETERMINE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS A BROKEN ROD AND IS PLANNING TO UNDERGO A REVISION SURGERY TO REMOVE THE CONSTRUCT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK