BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE UNIT COMPONENT OF IOTASOFT INSERTION SYSTEM

    MDR report key: 20422018 · Received October 10, 2024

    Report

    Report Number
    3030411493-2024-00002
    Event Type
    Malfunction
    Date Received
    October 10, 2024
    Date of Event
    September 10, 2024
    Report Date
    October 10, 2024
    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

    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 THE SCREW HEADS SEPARATED FROM THE SHAFT DURING THEIR REMOVAL. THE SURGEON THEN REMOVED THE SCREW SHAFTS BY DRILLING AROUND THEM TO LOOSEN THEM FROM THE SURROUNDING BONE AND WAS ABLE TO REMOVE BOTH SCREW SHAFTS IN THEIR ENTIRETY. SURGEON COMPLETED THE PROCEDURE SUCCESSFULLY. THE COMPANY SCREW PARTS WERE NOT RETURNED TO THE MANUFACTURER. IT WAS REPORTED THAT THE SURGEON DID NOT ELECT TO USE THE SCREWDRIVER THAT ACCOMPANIED THE STERILE, SINGLE USE DRIVE UNIT COMPONENT (RECOMMENDED FOR USE IN THE ACCOMPANYING IFU) BUT RATHER SOURCED THEIR OWN. 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
    1956797 DRIVE UNIT COMPONENT OF IOTASOFT INSERTION SYSTEM DRIVE UNIT QQH IOTAMOTION INC. IM-00 103443 00850002960006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Required Intervention