BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON AGILE SPINAL SYSTEM

    MDR report key: 1181766 · Received September 18, 2008

    Report

    Report Number
    1030489-2008-00529
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Report Date
    August 21, 2008
    Manufacturer
    WARSAW ORTHOPEDICS INC.
    Product Code
    NQP
    PMA / PMN Number
    K060615
    Removal / Correction Number
    1030489-122107-009-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    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 PT HAS A BROKEN ROD. A REVISION SURGERY HAS NOT BEEN SCHEDULED. THE SURGEON WILL CONTINUE TO MONITOR THE PT. NO PT COMPLICATIONS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK