MAUDE Adverse Event Report: NEOCIS INC YOMI GUIDED DENTAL IMPLANT ROBOT; DENTAL NAVIGATION SYSTEM

Health Effect - Clinical Codes	Failure of Implant (1924); Physical Entrapment (2327)
Date of Event	06/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
I was using the yomi robot to place dental implants on a sedated patient under the supervision of the company trainor.The robot arm was attached to the patient's anterior maxilla with four 3/4-inch stryker surgical screws.The surgery was going as planned when the robot very quickly and violently lifted my patient's head off the rest and slammed it down and pinned it against the chair eight inches to the left of the original position.I was unable to move the arm or the patient's head.The trainor was panicked and did not have an immediate solution.After a few minutes she was able to disable the robot and free the patient's head.The surgical fastening screws were loosened and bent at a 30-degree angle.Thank goodness the patient was a robust 200lb healthy 52-year-old man and was not seriously injured.If it would have been a more frail patient i believe this oculd have led to serious injury or death.We are able to reproduce the action the robot exhibited and the company is aware and has not been able to provide a solution.There are close to 200 of these fda approved robots in service and i am certain unless the problem is resolved there will be a tragic event.In addition, my anesthesiologist believes that with the robot arm attached it would be impossible to achieve positive pressure ventilation in an airway emergency.

• Brand Name: YOMI GUIDED DENTAL IMPLANT ROBOT
• Common Device Name: DENTAL NAVIGATION SYSTEM
• Manufacturer (Section D): NEOCIS INC
• MDR Report Key: 18783685
• Report Number: MW5151999
• Device Sequence Number: 19457672
• Product Code: QRY
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 02/21/2024

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/23/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FOUR STRYKER SURGICAL SCREWS.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White