BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVO SEEG ANCHOR BOLT

    MDR report key: 21276929 · Received January 30, 2025

    Report

    Report Number
    3016438686-2025-00001
    Event Type
    Injury
    Date Received
    January 30, 2025
    Date of Event
    November 4, 2024
    Report Date
    December 16, 2024
    Manufacturer
    NEUROONE MEDICAL TECHNOLOGIES CORP
    Product Code
    GZL
    PMA / PMN Number
    K222404
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    DURING INSERTION OF THE EVO SEEG 25MM ANCHOR BOLT IT WAS NOTED THE TIP IF THE BOLT PROTRUDED INTO THE PATIENT'S BRAIN TISSUE. THE PATIENT EXPERIENCED SOME LOSS OF FUNCTION IN THEIR RIGHT ARM; HOWEVER, IT IS UNCLEAR HOW MUCH OF THE WEAKNESS COULD BE RELATED TO THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781454 EVO SEEG ANCHOR BOLT ELECTRODE DEPTH ANCHOR BOLT GZL NEUROONE MEDICAL TECHNOLOGIES CORP NSEEG0025 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Female Disability