BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERVICAL STIM SPINAL FUSION THERAPY

    MDR report key: 18759193 · Received February 21, 2024

    Report

    Report Number
    MW5151822
    Event Type
    Injury
    Date Received
    February 21, 2024
    Date of Event
    February 17, 2024
    Report Date
    February 17, 2024
    Manufacturer
    ORTHOFIX US LLC
    Product Code
    LOF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WHILE WEARING THE ORTHOFIX CERVICALSTIM SPINAL FUSION THERAPY¿©®? DEVICE, I NOTICED THAT THE OUTER EDGES OF MY EARS WERE UNCOMFORTABLE WHILE IN CLOSE PROXIMITY (1-2 CM) OR WHILE IN CONTACT WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237563 CERVICAL STIM SPINAL FUSION THERAPY STIMULATOR, BONE GROWTH, NON-INVASIVE LOF ORTHOFIX US LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male