BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CMF SPINALOGIC - BONE GROWTH STIMULATOR

    MDR report key: 6961077 · Received October 19, 2017

    Report

    Report Number
    MW5072830
    Event Type
    Injury
    Date Received
    October 19, 2017
    Date of Event
    April 7, 2017
    Report Date
    October 11, 2017
    Manufacturer
    DJO GLOBAL
    Product Code
    LOF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD 2 LEVEL LUMBAR SURGERY L4-S1 ON (B)(6) 2017. I WAS TOLD BY THE NEUROSURGEON TO USE THIS DEVICE FOR 2 MONTHS TO HELP WITH THE FUSION/BONE GROWTH PROCESS. I STARTED ON (B)(6) 2017 AND STOPPED AFTER 40 DAYS OF DAILY USE. THE DEVICE AUTOMATICALLY SHUTS OFF AFTER 30 MINUTES AND ALLOWS ONLY DAILY USE. IT IS PROGRAMMED. THE DEVICE COVERED ALL OF MY LUMBAR AND THORACIC SPINE AREAS. SLOWLY OVER THIS TIME, I NOTICED A LOT OF WEAKNESS/PAIN IN THE BONES ESPECIALLY THE SACRUM, HIPS, T-SPINE AND RIBS, NECK AND DOWN TO THE ANKLE JOINTS. AROUND THE ANKLE JOINTS, I FELT I WOULD FRACTURE THE BONE. I ALSO FACED EXTREME FATIGUE DURING THE TIME I USED THIS DEVICE. IT IS MY BELIEF THAT IT WORSENED OR WEAKENED AREAS OF MY SPINE I.E. NECK AND THORACIC SPINE WHICH ALREADY HAVE DEGENERATIVE DISC DISEASE/ARTHRITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743490 CMF SPINALOGIC - BONE GROWTH STIMULATOR CMF SPINALOGIC - BONE GROWTH STIMULATOR LOF DJO GLOBAL

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Disability