BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE UNIT COMPONENT OF IOTASOFT INSERTION SYSTEM

    MDR report key: 21944040 · Received May 1, 2025

    Report

    Report Number
    3030411493-2025-00005
    Event Type
    Malfunction
    Date Received
    May 1, 2025
    Date of Event
    April 1, 2025
    Report Date
    May 1, 2025
    Manufacturer
    IOTAMOTION INC.
    Product Code
    QQH
    UDI-DI
    00850002960006
    PMA / PMN Number
    DEN190055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IOTAMOTION IS CURRENTLY INVESTIGATING.

    Description of Event or Problem · 0

    IT WAS REPORTED TO THE COMPANY THAT AFTER A SUCCESSFUL CI ELECTRODE ARRAY PLACEMENT, THE BASE OF THE DRIVE UNIT WAS BEING REMOVED FROM ITS FIXATION (2 SELF-DRILLING SCREWS) ON THE SKULL AND ONE (1) OF THE SCREW HEADS SEPARATED FROM THE SHAFT DURING THE REMOVAL. THE SURGEON WAS ABLE TO REMOVE THE SCREW SHAFT IN ITS ENTIRETY. SURGEON COMPLETED THE PROCEDURE SUCCESSFULLY. THE BROKEN SCREW WAS RETURNED TO THE MANUFACTURER. NO PATIENT HARM REPORTED. FOLLOW-UP STATUS ON PATIENT RECOVERY AND SAFE AND EFFECTIVE USE WITH IMPLANT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1655805 DRIVE UNIT COMPONENT OF IOTASOFT INSERTION SYSTEM DRIVE UNIT QQH IOTAMOTION INC. IM-00 103465 00850002960006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention