BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVE UNIT COMPONENT OF IOTASOFT INSERTION SYSTEM

    MDR report key: 20107389 · Received August 30, 2024

    Report

    Report Number
    3030411493-2024-00001
    Event Type
    Malfunction
    Date Received
    August 30, 2024
    Date of Event
    July 30, 2024
    Report Date
    August 28, 2024
    Manufacturer
    IOTAMOTION INC.
    Product Code
    QQH
    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

    MANUFACTURER REPRESENTATIVE PRESENT AT SURGERY ADN REPORTED AT CONCLUSION OF USE OF THE MEDICAL DEVICE (FOLLOWING STANDARD PROCEDURES), THE BASE OF THE DRIVE UNIT WAS BEING REMOVED FROM ITS FIXATION (2 SELF-DRILLING SCREWS) ON THE SKULL AND THE SCREW HEAD SEPARATED FROM THE SHAFT ON ONE OF THE TWO SCREWS DURING THEIR REMOVAL. ONE SCREW WAS REMOVED INTACT, THE OTHER SEPARATED (HEAD FROM SHAFT) WITH THE REMOVAL OF THE SCREW HEAD CONSIDERED UNREMARKABLE. THE SURGEON THEN REMOVED THE SCREW SHAFT BY DRILLING AROUND IT TO LOOSEN IT FROM THE SURROUNDING BONE AND WAS ABLE TO REMOVE IT IN ITS ENTIRETY. SURGEON COMPLETED THE PROCEDURE SUCESSFULLY. MANUFACTURER REPRESENTATIVE REQUESTED RETURN OF BOTH PIECES OF SCREW TO COMPANY FOR EVALUATION. 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. THE COMPONENT (SCREW) IS UNDERGOING INHOUSE AND LABORATORY INSPECTION TO ASCERTAIN CAUSE OF SCREW FAILURE. FOLLOW-UP STATUS ON PATIENT RECOVERY AND SAFE AND EFFECTIVE USE WITH IMPLANT WILL ALSO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1990271 DRIVE UNIT COMPONENT OF IOTASOFT INSERTION SYSTEM DRIVE UNIT QQH IOTAMOTION INC. IM-00 103443

    Patients

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