BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPF IMPLANTABLE SPINAL FUSION STIMULATOR

    MDR report key: 424549 · Received October 24, 2002

    Report

    Report Number
    2242816-2002-00019
    Event Type
    Other
    Date Received
    October 24, 2002
    Report Date
    October 23, 2002
    Manufacturer
    EBI, L.P.
    Product Code
    GZB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON OCTOBER 1, 2002 AN SPF SPINAL FUSION STIMULATOR WAS IMPLANTED INTO THE PATIENT. SUBSEQUENT TO THAT DATE THE DEVICE WAS REMOVED BECAUSE THE MD FELT THE PATIENT MAY HAVE DEVELOPED AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPF IMPLANTABLE SPINAL FUSION STIMULATOR IMPLANTABLE STIMULATOR GZB EBI, L.P. 10-1385M NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other