BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KYPHON

    MDR report key: 939364 · Received November 5, 2007

    Report

    Report Number
    MW5004326
    Event Type
    Malfunction
    Date Received
    November 5, 2007
    Date of Event
    October 19, 2007
    Report Date
    November 5, 2007
    Manufacturer
    KYPHON, INC.
    Product Code
    OCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING FUNCTIONAL ANESTHETIC DISCOGRAM IN HOSP PAIN CLINIC, IT WAS NOTED THAT A SMALL PORTION OF A GUIDE WIRE FRACTURED AND WAS RETAINED IN DISK L4-L5. THE PHYSICIAN DID NOT REMOVE THE WIRE; HE NOTIFIED THE MFR WHO STATES THEY HAVE FORWARDED THIS INFORMATION TO THE FDA. LOT NUMBER UNCLEAR. PLEASE SEE FOLLOWING LOT NUMBERS FOR POTENTIAL MATCH. THESE WERE DERIVED FROM SHIPMENTS SURROUNDING AFFECTED PROCEDURE. J7053011, J7090623, J7080606, J7073012, J7060603.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KYPHON FAD CATHETER SYSTEM OCJ KYPHON, INC. FAD CATHETER J7090623

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other