MAUDE Adverse Event Report: iotaMotion Inc. Drive Unit component of iotaSOFT Insertion System

Model Number	IM-05
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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 3 mm in length with a 1 mm diameter.Investigation completed.
Event or Problem Description
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 inhouse inspection to ascertain cause of screw 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 3 mm in length with a 1 mm diameter.

• Brand Name: Drive Unit component of iotaSOFT Insertion System
• Common Device Name: Drive Unit
• Manufacturer (Section D): iotaMotion Inc.; 4205 white bear parkway; suite 600; st. paul 55110
• Manufacturer (Section G): Nextern; 10601 fountains drive; maple grove 55369
• Manufacturer Contact: khamporn pendergrass ; 4205 white bear parkway; suite 600; st. paul 55110 ; +1(651)447-4177
• MDR Report Key: 20812304
• Report Number: 3030411493-2024-00003
• Device Sequence Number: 15937806
• Product Code: QQH
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: DEN190055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/27/2025
• Device Model Number: IM-05
• Device Lot Number: 502480
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/05/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 11/29/2024
• Supplement Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown