BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON AGILE SPINAL SYSTEM

    MDR report key: 1152834 · Received September 4, 2008

    Report

    Report Number
    1030489-2008-00491
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    August 12, 2008
    Report Date
    August 7, 2008
    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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO MEDTRONIC FOR EVAL. IT WAS REPORTED THAT THE PT HAS POSSESSION OF THE DEVICES AND WILL NOT RELEASE THEM FOR EVAL. UNABLE TO DETERMINE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A REVISION SURGERY TO REMOVE A POSTERIOR CONSTRUCT WITH A FRACTURED ROD AND REPLACE WITH A NEW CONSTRUCT. NO PT COMPLICATIONS WERE REPORT.

    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 54 YR Required Intervention