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	05/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Head cap dislodged from the handpiece during use.
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: 25553240
• Report Number: 25553240
• Device Sequence Number: 21519180
• 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
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2026
• Report Date (Section F): 08/12/2026

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?: Yes
• Date Returned to Manufacturer: 06/22/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/19/2026
• Device Age: 4 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 08/12/2026
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/18/2026
• Supplement Report FDA Received Date: 08/12/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 36 YR
• Patient Sex: Female
• Date Report Sent to FDA: 08/12/2026