BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE STIMULATOR PHYSIOSTIM

    MDR report key: 20312282 · Received September 25, 2024

    Report

    Report Number
    MW5160140
    Event Type
    Malfunction
    Date Received
    September 25, 2024
    Date of Event
    September 22, 2024
    Report Date
    September 23, 2024
    Manufacturer
    ORTHOFIX US LLC
    Product Code
    LOF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ORTHO FIX BONE STIMULATOR (SN: (B)(6) INACTIVATES A PERFECTLY GOOD AND FUNCTIONAL UNIT THOUGH I AM THE ORIGINAL AND ONLY USER, FOR THE SOLE PURPOSE OF GETTING REIMBURSED BY THE INSURANCE COMPANY AND MY PAYING A NEW COINSURANCE FEE SO THEY CAN BOOST SALES. THIS HAS NOTHING TO DO WITH THE UNIT OR PROBLEMS WITH THE UNIT OR MALFUNCTION OF THE UNIT; RATHER IT IS A PURE AND SIMPLE PLOY TO INCREASE SALES. IT IS OBSCENE. THIS ACTION CONTRIBUTES TO ADDED AND UNNECESSARY HEALTHCARE EXPENSES AND PERSONAL MEDICAL EXPENSES DUE TO THIS FRAUD. MY DOCTOR AND I DECIDED TO CONTINUE ITS USE THROUGH A SHARED DECISION-MAKING MODEL AND NOW, I AM AT FURTHER RISK OF NONUNION DUE TO ORTHFOFIX'S GREED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052912 BONE STIMULATOR PHYSIOSTIM STIMULATOR, BONE GROWTH, NON-INVASIVE LOF ORTHOFIX US LLC 5303

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male ADVAIR.| CRESTOR.