BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM

    MDR report key: 6554161 · Received May 9, 2017

    Report

    Report Number
    0002242816-2017-00021
    Event Type
    Injury
    Date Received
    May 9, 2017
    Report Date
    May 9, 2017
    Manufacturer
    EBI, LLC.
    Product Code
    LOF
    PMA / PMN Number
    PP850022
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    G5 PMA/510(K) NUMBER: P850022/S017. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    THE PATIENT STATED HE WAS USING THE SPINALPAK TO TREAT HIS BACK, HE CANNOT REMEMBER WHEN THE EVENT OCCURRED; HE REPORTS A SPARK FROM HIS 20' LEAD WIRE CAUSED A BURN. HE STATED HE WAS GIVEN AN ANTIBIOTIC CREAM, HOWEVER HE CANNOT REMEMBER THE NAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335820 SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM 20" LEAD WIRES LOF EBI, LLC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention