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., 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
• MDR Report Key: 19122839
• MDR Text Key: 341149965
• Report Number: 3010364969-2024-00007
• 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): Y
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 82 YR
• Patient Sex: Male