BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPF-PLUS-MINI SPINAL STIMULATOR

    MDR report key: 23084687 · Received September 18, 2025

    Report

    Report Number
    MW5176231
    Event Type
    Malfunction
    Date Received
    September 18, 2025
    Date of Event
    August 9, 2023
    Report Date
    September 17, 2025
    Manufacturer
    EBI, LLC/ZIMVIE INC.
    Product Code
    LOE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT IS REPORTING ON A SPINAL STIMULATOR THAT SHE DIDN'T KNOW WAS IMPLANTED. (B)(6) 2023 PATIENT WAS IN THE HOSPITAL AT (B)(6) HOSPITAL IN (B)(6). DURING THIS VISIT PATIENT HAD A LUMBAR FUSION BUT WASN'T AWARE THAT A SPINAL STIMULATOR WOULD BE IMPLANTED. PATIENT HAD NO COMPLICATIONS THEREAFTER. (B)(6) 2025, PATIENT TRIPPED AND FELL AND WENT TO THE EMERGENCY ROOM AT THE SAME FACILITY. DURING THIS VISIT SHE WAS INFORMED THAT SHE HAD A SPINAL STIMULATOR IN HER BACK. THE FIRST FEW DAYS AFTER THE FALL SHE EXPERIENCED PAIN AND HAD BRUISES TO HER HANDS, WRISTS, AND KNEES. THREE TO FIVE DAYS AFTER THE FALL HER SYMPTOMS SPIKED. SHE EXPERIENCED A PARALYZING EFFECT ON EVERYTHING FROM HER TORSO ALL THE WAY DOWN THROUGH HER LEGS. HER HAND/EYE COORDINATION WAS OFF AND SHE HAD ZERO BALANCE. PATIENT HAS HAD DEGENERATIVE BACK ISSUES SINCE 2022 BUT NEVER EXPERIENCED ANYTHING SO PAINFUL. IN (B)(6) 2025 SHE WAS HOSPITALIZED FOR A SEPTIC INFECTION THAT SHE FEELS THE SPINAL STIMULATOR COULD HAVE CONTRIBUTED TO. PATIENT CONDUCTED SOME RESEARCH ON THE DEVICE AND THE DEVICE MAY HAVE BEEN RECALLED IN 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317583 SPF-PLUS-MINI SPINAL STIMULATOR STIMULATOR, INVASIVE BONE GROWTH LOE EBI, LLC/ZIMVIE INC. 10-1398M

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other