BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CMF SPINALOGIC

    MDR report key: 8697774 · Received June 13, 2019

    Report

    Report Number
    3012446970-2019-00015
    Event Type
    Malfunction
    Date Received
    June 13, 2019
    Date of Event
    May 24, 2019
    Report Date
    July 10, 2019
    Manufacturer
    DJO, LLC
    Product Code
    LOF
    UDI-DI
    00888912011495
    PMA / PMN Number
    P910066
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ONE SPINALOGIC (PRODUCT NUMBER 01-207-0007, SERIAL NUMBER (B)(4) WAS RETURNED FOR EVALUATION. FULL TREATMENT WAS RUN AT TEST STATION AND A 30-MINUTE BATTERY TREATMENT WAS RUN. THE PRODUCT MET SPECIFICATIONS AND DID NOT MALFUNCTION. PRODUCTION RECORDS WERE REVIEWED AND THERE WERE NO FINDINGS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    NO DEVICE WAS RETURNED FOR EVALUATION. IF THE DEVICE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF PRODUCT EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SITTING IN A CHAIR USING HER SPINALOGIC AND SHE FELT SOMETHING WARM. SHE STOOD UP AND IMMEDIATELY REMOVED THE DEVICE. SHE TOOK OFF THE DEVICE AND IT HAD BURNED TWO HOLES INTO TWO OF HER SHIRTS, A T-SHIRT AND A BLOUSE. THERE WAS REPORTEDLY NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491018 CMF SPINALOGIC STIMULATOR, BONE GROWTH, NON-INVASIVE LOF DJO, LLC 01-207-0007 00888912011495

    Patients

    Seq Age Sex Outcome Treatment
    1