MAUDE Adverse Event Report: TTBIO CORP MAXIMA PRO 2; HANDPIECE

Model Number	MAXIMA PRO 2 STD HEAD
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Choking (2464)
Date of Event	04/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Handpiece cap came off while in patient's mouth during a crown prep procedure.

• Brand Name: MAXIMA PRO 2
• Common Device Name: HANDPIECE
• Manufacturer (Section D): TTBIO CORP; 2f, no. 7, 6th road; industry pa; taichung, 40755 ; TW 40755
• MDR Report Key: 17008293
• Report Number: 3007007357-2023-00004
• Device Sequence Number: 7538428
• Product Code: EFB
• UDI-Device Identifier: 00304040090046
• UDI-Public: 00304040090046
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/25/2023
• Report Date (Section F): 05/25/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: MAXIMA PRO 2 STD HEAD
• Device Catalogue Number: 570-1072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2023
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/04/2023
• Device Age: 5 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/25/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/25/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Date Report Sent to FDA: 05/25/2023