BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINALSTIM BONE GROWTH STIMULATOR

    MDR report key: 18564373 · Received January 22, 2024

    Report

    Report Number
    MW5150646
    Event Type
    Injury
    Date Received
    January 22, 2024
    Report Date
    January 19, 2024
    Manufacturer
    ORTHOFIX US LLC
    Product Code
    LOF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE REASON FOR CALL WAS PATIENT REPORTED THEIR MACHINE GAVE THEM A REACTION AND IRRITATED THEIR WHOLE CHEST; THE ISSUE BEGAN THEY WOULD SAY 4 MONTHS AGO OR IN AUGUST. PATIENT HAD AN ORTHOFIX DEVICE WITH A (B)(6) SERIAL NUMBER. AGENT TRANSFERRED PATIENT TO ORTHOFIX. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REFER TO ADD'L DOCUMENTS IN I2K.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1953789 SPINALSTIM BONE GROWTH STIMULATOR STIMULATOR, BONE GROWTH, NON-INVASIVE LOF ORTHOFIX US LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown