BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPF IMPLANTABLE SPINAL FUSION STIMULATOR

    MDR report key: 277477 · Received May 10, 2000

    Report

    Report Number
    2242816-2000-00010
    Event Type
    Other
    Date Received
    May 10, 2000
    Date of Event
    April 27, 1998
    Report Date
    May 8, 2000
    Manufacturer
    EBI, L.P.
    Product Code
    LOE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    AN SPF DEVICE WAS IMPLANTED IN THE PT IN 1998 FOR AN L4-5 FUSION. THE DEVICE WAS EXPLANTED IN 1998 DUE TO AN INFECTION AT THE SURGICAL SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPF IMPLANTABLE SPINAL FUSION STIMULATOR IMPLANTABLE BONE GROWTH STIMULATOR LOE EBI, L.P. 10-1385W *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other