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

Model Number MAXIMA PRO 2

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem Laceration(s) (1946)

Event Date 03/22/2022

Event Type  Injury  

Event Description

Dentist used two new handpieces during normal composite filling procedures with two different patients.One female patient received minor laceration in the mouth during a procedure, due to a bur that was coming out of the handpiece.No specifications of the bur could be provided but the office did indicate that it was an ss white bur.Dentist applied on some antiseptic on the small laceration received.Male patient almost swallowed the same type of bur but dentist was able to be retrieve with no patient harm.Office indicated that they unable to determine which serial number handpiece was with what patient.The burs were coming out fairly easy for new handpieces.

• 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: 14164563
• MDR Text Key: 289734183
• Report Number: 3007007357-2022-00004
• Device Sequence Number: 1
• Product Code: EFB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAXIMA PRO 2
• Device Catalogue Number: 570-1072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2022
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/20/2022
• Distributor Facility Aware Date: 03/24/2022
• Device Age: 7 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/20/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female