BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPF XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR

    MDR report key: 23878958 · Received December 23, 2025

    Report

    Report Number
    MW5181065
    Event Type
    Injury
    Date Received
    December 23, 2025
    Date of Event
    March 12, 2016
    Report Date
    December 18, 2025
    Manufacturer
    EBI PATIENT CARE, INC.
    Product Code
    LOE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE REPORTER CALLED REGARDING THEIR SPINAL FUSION STIMULATOR, WHICH THEY DISCOVERED IS ON RECALL LIST, AND WANTED TO REPORT THE DEVICE IS CURRENTLY IMPLANTED AND THAT THEY HAVE BEEN EXPERIENCING SYMPTOMS INCLUDING URINARY TRACT INFECTION, SKIN IRRITATION, AND CRAMPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2506939 SPF XL IIB IMPLANTABLE SPINAL FUSION STIMULATOR STIMULATOR, INVASIVE BONE GROWTH LOE EBI PATIENT CARE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male