BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE UNIT COMPONENT OF IOTASOFT INSERTION SYSTEM

    MDR report key: 24554415 · Received March 9, 2026

    Report

    Report Number
    3030411493-2026-00001
    Event Type
    Malfunction
    Date Received
    March 9, 2026
    Date of Event
    February 2, 2026
    Report Date
    March 6, 2026
    Manufacturer
    IOTAMOTION INC.
    Product Code
    QQH
    UDI-DI
    00850002960068
    PMA / PMN Number
    K252339
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED TO THE COMPANY THAT AFTER A SUCCESSFUL CI ELECTRODE ARRAY PLACEMENT, DURING THE REMOVAL OF THE DRIVE UNIT BASE FROM ITS FIXATION (2 SELF-DRILLING SCREWS) ON THE SKULL THE BONE SCREW HEADS SEPARATED FROM THE SHAFT DURING THEIR REMOVAL. THE SURGEON WAS ABLE TO REMOVE BOTH SCREW SHAFTS IN THEIR ENTIRETY AND COMPLETED THE PROCEDURE SUCCESSFULLY. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614825 DRIVE UNIT COMPONENT OF IOTASOFT INSERTION SYSTEM DRIVE UNIT QQH IOTAMOTION INC. IM-05 505238 00850002960068

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention