MAUDE Adverse Event Report: TTBIO CORP MEDIDENTA; HANDPIECE

Model Number	TURBO TORQUE 2200
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	04/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Head cap dislodged from the handpiece during use.

• Brand Name: MEDIDENTA
• Common Device Name: HANDPIECE
• Manufacturer (Section D): TTBIO CORP; 2f, no. 7, 6th road; industry pa; taichung, 40755 ; TW 40755
• MDR Report Key: 25086238
• Report Number: 3007007357-2026-00011
• Device Sequence Number: 10403403
• Product Code: EFB
• UDI-Device Identifier: 00810988030902
• UDI-Public: (01)00810988030902
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2026
• Report Date (Section F): 05/05/2026

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: TURBO TORQUE 2200
• Device Catalogue Number: TT2200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2026
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/08/2026
• Device Age: 17 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 05/08/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/05/2026
• 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: 46 YR
• Patient Sex: Female
• Date Report Sent to FDA: 05/05/2026