BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE UNIT COMPONENT OF IOTASOFT INSERTION SYSTEM

    MDR report key: 20812304 · Received November 29, 2024

    Report

    Report Number
    3030411493-2024-00003
    Event Type
    Malfunction
    Date Received
    November 29, 2024
    Date of Event
    October 31, 2024
    Report Date
    November 29, 2024
    Manufacturer
    IOTAMOTION INC.
    Product Code
    QQH
    UDI-DI
    00850002960068
    PMA / PMN Number
    DEN190055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE BONE SCREW IS MACHINED FROM TITANIUM TI 6AL 4V-ELI (ASTM F136 STANDARD SPECIFICATION FOR WROUGHT TITANIUM-6ALUMINUM-4VANADIUM ELI (EXTRA LOW INTERSTITIAL) ALLOY FOR SURGICAL IMPLANT APPLICATIONS) WHICH IS COMMONLY USED FOR IMPLANTS SUCH AS PLATE/SCREWS FOR BONE FIXATION. TITANIUM IS NON-MAGNETIC THEREFORE, THE RISK OF ANY CI OR MRI INTERFERENCE IS MINIMAL. TITANIUM IS GENERALLY CONSIDERED SAFE AND COMPATIBLE WITH MRI AND DOES NOT INTERFERE SIGNIFICANTLY WITH THE MAGNETIC FIELD OF THE MRI. IN ADDITION, THE SIZE OF THE BONE SCREW THAT WAS LEFT IN PLACE IS APPROXIMATELY 3MM IN LENGTH WITH A 1MM DIAMETER.

    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 DECIDED TO LEAVE THE SCREW IN THE SKULL AND USED THE DRILL TO SMOOTH DOWN ANY PROTRUSION OF THE SCREW. SURGEON COMPLETED THE PROCEDURE SUCCESSFULLY. THE BROKEN SCREW HEAD WAS RETURNED TO THE MANUFACTURER. THE COMPONENT (SCREW) IS UNDERGOING IN HOUSE INSPECTION TO ASCERTAIN CAUSE OF SREW FAILURE. FOLLOW-UP STATUS ON PATIENT RECOVERY AND SAFE AND EFFECTIVE USE WITH IMPLANT WILL BE MONITORED. THE BONE SCREW IS MACHINED FROM TITANIUM TI 6AL 4V-ELI (ASTM F136 STANDARD SPECIFICATION FOR WROUGHT TITANIUM-6ALUMINUM-4VANADIUM ELI (EXTRA LOW INTERSTITIAL) ALLOY FOR SURGICAL IMPLANT APPLICATIONS) WHICH IS COMMONLY USED FOR IMPLANTS SUCH AS PLATE/SCREWS FOR BONE FIXATION. TITANIUM IS NON-MAGNETIC THEREFORE, THE RISK OF ANY CI OR MRI INTERFERENCE IS MINIMAL. TITANIUM IS GENERALLY CONSIDERED SAFE AND COMPATIBLE WITH MRI AND DOES NOT INTERFERE SIGNIFICANTLY WITH THE MAGNETIC FIELD OF THE MRI. IN ADDITION, THE SIZE OF THE BONE SCREW THAT WAS LEFT IN PLACE IS APPROXIMATELY 3MM IN LENGTH WITH A 1MM DIAMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2617970 DRIVE UNIT COMPONENT OF IOTASOFT INSERTION SYSTEM DRIVE UNIT QQH IOTAMOTION INC. IM-05 502480 00850002960068

    Patients

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