BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERVICALSTIM BONE GRAFT STIMULATOR

    MDR report key: 24561051 · Received March 10, 2026

    Report

    Report Number
    MW5185017
    Event Type
    Injury
    Date Received
    March 10, 2026
    Date of Event
    January 2, 2026
    Report Date
    March 5, 2026
    Manufacturer
    ORTHOFIX US LLC.
    Product Code
    LOF
    UDI-DI
    1825720015632
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    AFTER 4 DAYS OF USE OF ORTHO FIX CERVICALSTIM, DEVELOPED SEVERE NEURALGIA PAIN AND NUMBNESS IN LEFT SHOULDER, LEFT ARM TO HAND, WITH INCREASED WEAKNESS. ALSO HAD INCREASED NUMBNESS IN RIGHT HAND. HAD ALOT OF PAIN IN NECK AS WELL. TOOK ALMOST A WEEK FOR MOST SYMPTOMS TO RESOLVE, STILL HAD SLIGHT RESIDUAL FOR ANOTHER WEEK OR TWO. I REPORTED IT TO THE REPRESENTATIVE WHO DIDN'T GET TO ME UNTIL I CALLED BACK THE FOLLOWING WEEK. I DOUBTED THAT THEY WOULD REPORT THE ADVERSE EFFECTS SO I AM DOING IT. PRODUCT BROCHURE HAD VAGUE MISLEADING ASSURANCES OF DEVICE SAFETY, WHICH TOOK NO RESPONSIBILITY AND ABSOLVED THEMSELVES OF ANY ADVERSE EFFECTS THAT MAY HAVE BEEN PREVIOUSLY REPORTED BY PATIENTS. NOTE: THEY ALSO DIDN'T REVERSE THE DEVICE CHARGE, SO THEY GOT SIGNIFICANT PAYMENT FOR MEDICARE ALTHOUGH DEVICE BRIEF TRIAL CAUSED SEVERE SIDE EFFECTS. PICTURES OF DEVICE WITH BAR CODES ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616135 CERVICALSTIM BONE GRAFT STIMULATOR STIMULATOR, BONE GROWTH, NON-INVASIVE LOF ORTHOFIX US LLC. 5505 655505-001 1825720015632

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Other C FIBERCON| CELEBREX| CRESTOR| DEXILANT| GABAPENTIN| MULTIVITAMIN| ROBAXIN| TRAMADOL| VITAMIN D