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

Model Number MAXIMA PRO 2 HP STD HEAD

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

Handpiece head exploded while being used in a patient's mouth and broke apart.No harm to the patient.

• Brand Name: MAXIMA PRO 2 HP STD. HEAD
• Type of Device: HANDPIECE
• Manufacturer (Section D): TTBIO CORP.; 2f, no. 7, 6th road; industry park; taichung, taiwan 40755 ; TW 40755
• Manufacturer (Section G): TTBIO CORP.; 2f, no. 7, 6th road; industry park; taichung, taiwan 40755 ; TW 40755
• Manufacturer Contact: jun li ; 2f, no. 7, 6th road; industry park; taichung, taiwan 40755 ; TW 40755
• MDR Report Key: 18532483
• MDR Text Key: 333119063
• Report Number: 3010364969-2024-00001
• Device Sequence Number: 1
• Product Code: EFB
• UDI-Device Identifier: 00304040090046
• UDI-Public: 0100304040090046
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAXIMA PRO 2 HP STD HEAD
• Device Catalogue Number: 570-1072
• Was Device Available for Evaluation?: No
• 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 Age: 12 YR
• Patient Sex: Female