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

Model Number MAXIMA PRO 2 STD HEAD

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/29/2023

Event Type  malfunction  

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 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
• MDR Text Key: 318034302
• Report Number: 3010364969-2023-00002
• Device Sequence Number: 1
• Product Code: EFB
• UDI-Device Identifier: 00304040090046
• UDI-Public: 00304040090046
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• 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?: Yes
• Date Manufacturer Received: 05/29/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male