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

Model Number	MAXIMA PRO 2 STD HEAD
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2023
Type of Reportable Event	Malfunction
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 park; taichung, 40755 ; TW 40755
• Manufacturer (Section G): TTBIO CORP.; 2f., no.7, 6th road; industry park; taichung, 40755 ; TW 40755
• Manufacturer Contact: jun li ; 2f., no.7, 6th road; industry park; taichung, 40755 ; TW 40755
• MDR Report Key: 17218655
• Report Number: 3010364969-2023-00002
• Device Sequence Number: 6232771
• Product Code: EFB
• UDI-Device Identifier: 00304040090046
• UDI-Public: 00304040090046
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/30/2023

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2023
• Initial Report FDA Received Date: 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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