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

Model Number MAXIMA PRO 2 STD HEAD

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Choking (2464)

Event Date 04/29/2023

Event Type  Injury  

Event Description

Handpiece cap came off while in patient's mouth during a crown prep procedure.

• Brand Name: MAXIMA PRO 2
• Type of Device: HANDPIECE
• Manufacturer (Section D): TTBIO CORP; 2f, no. 7, 6th road; industry pa; taichung, 40755 ; TW 40755
• MDR Report Key: 17008293
• MDR Text Key: 315990587
• Report Number: 3007007357-2023-00004
• Device Sequence Number: 1
• Product Code: EFB
• UDI-Device Identifier: 00304040090046
• UDI-Public: 00304040090046
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Date Report Sent to FDA: 05/25/2023
• 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 Manufacturer Received: Not provided
• Initial Date FDA Received: 05/25/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male