MAUDE Adverse Event Report: TTBIO CORP. MAXIMA PRO 2L HP MINI HEAD F/O; HANDPIECE

Model Number MAXIMA PRO 2L HP MINI HEAD F/O

Device Problem Insufficient Information (3190)

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

Event Date 01/23/2024

Event Type  malfunction  

Event Description

Per dentist, the motor didn't "blow up", the push button on the top, it had separated and came apart during use while doing a lower filling procedure.The patient wasn't aware of the incident, and they used a different handpiece.The patient was an 82 year old male and no medical attention was required.

• Brand Name: MAXIMA PRO 2L HP MINI HEAD F/O
• Type of Device: HANDPIECE
• Manufacturer (Section D): TTBIO CORP.; 2f, 7 6th road; industry pa,, taichung 40755 ; TW 40755
• MDR Report Key: 18903811
• MDR Text Key: 337661713
• Report Number: 3007007357-2024-00007
• 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: Dentist
• Type of Report: Initial
• Report Date: 03/14/2024,03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAXIMA PRO 2L HP MINI HEAD F/O
• Device Catalogue Number: 570-1073
• Device Lot Number: 73088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/14/2024
• Distributor Facility Aware Date: 02/16/2024
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 03/14/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Male