BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON SPINAL SYSTEM

    MDR report key: 1181768 · Received September 18, 2008

    Report

    Report Number
    1030489-2008-00530
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    January 1, 2007
    Report Date
    August 20, 2008
    Manufacturer
    WARSAW ORTHOPEDIC INC.
    Product Code
    KWP
    PMA / PMN Number
    K040962
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 IN 2005 THE PATIENT UNDERWENT A MULTIPLE LEVEL SPINAL SURGERY EXTENDING TO THE ILIAC. TI WAS REPORTED THAT IN 2007 A ROD WAS BROKEN NEAR THE BOTTOM OF THE CONSTRUCT. NO REVISION SURGERY WAS REPORTED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR