BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON AGILE SPINAL SYSTEM

    MDR report key: 1307891 · Received February 5, 2009

    Report

    Report Number
    1030489-2009-00103
    Event Type
    Injury
    Date Received
    February 5, 2009
    Date of Event
    November 1, 2008
    Report Date
    January 9, 2009
    Manufacturer
    WARSAW ORTHOPEDIC 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
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 THE PATIENT UNDERWENT L4-S1 FUSION WITH IMPLANT OF POSTERIOR ROD/PEDICLE SCREW FIXATION L3-S1, DYNAMIC SEGMENT AT L3-4. SOMETIME POST-OP, A ROD WAS BROKEN AND THE PATIENT UNDERWENT A REVISION SURGERY TO REMOVE HARDWARE AND FUSE L3-4.

    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 Required Intervention