MAUDE Adverse Event Report: TTBio Corp Henry Schein; Handpiece

Model Number	Maxima Advance Standard Optic
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2026
Type of Reportable Event	Serious Injury

• Brand Name: Henry Schein
• Common Device Name: Handpiece
• Manufacturer (Section D): TTBio Corp; 2f, no . 7 6th road; industry pa, taichung 40755 ; TW 40755
• MDR Report Key: 50737460
• Report Number: 3007007357-2026-00014
• Device Sequence Number: 21487925
• Product Code: EFB
• UDI-Device Identifier: 00304040179864
• UDI-Public: 00304040179864
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 09/11/2026
• Report Date (Section F): 09/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: Maxima Advance Standard Optic
• Device Catalogue Number: 575-0532
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/13/2026
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 09/11/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Sex: Male
• Date Report Sent to FDA: 09/11/2026