BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1210750 · Received October 23, 2008

    Report

    Report Number
    1030489-2008-00589
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    September 25, 2008
    Report Date
    September 25, 2008
    Manufacturer
    WARSAW ORTHOPAEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES HAVE NOT BEEN RETURNED TO MEDTRONIC FOR EVALUATION. UNABLE TO DETERMINE THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY TO REPLACE BROKEN RODS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD HORIZON SPINAL SYSTEM ROD KWP WARSAW ORTHOPAEDIC INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention