MAUDE Adverse Event Report: THINK SURGICAL, INC TMINI MINIATURE ROBOTIC SYSTEM; ORTHOPEDIC STERIOTAXIC INSTRUMENT

Model Number	108757
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Data Problem (3196)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The tnav cart prompts the surgeon to confirm the selected implant and surgical plan prior to use; however, an anterior referencing plan was uploaded despite the surgeon's request for posterior referencing.The event is under investigation to determine the cause of the discrepancy, including evaluation of plan selection, review, or confirmation step.A supplemental report will be submitted upon completion of the investigation, if required.
Event or Problem Description
The surgeon requested a posterior referencing plan; however, an anterior referencing plan was uploaded for the procedure.The discrepancy was identified prior to the procedure during the confirmation of instruments screen on the tmini navigation console.

• Brand Name: TMINI MINIATURE ROBOTIC SYSTEM
• Common Device Name: ORTHOPEDIC STERIOTAXIC INSTRUMENT
• Manufacturer (Section D): THINK SURGICAL, INC; 47201 lakeview blvd; fremont CA 94538
• Manufacturer (Section G): THINK SURGICAL, INC; 47201 lakeview blvd; fremont CA 94538
• Manufacturer Contact: jason erickson ; 47201 lakeview blvd; fremont, CA 94538 ; 7077044558
• MDR Report Key: 24280655
• Report Number: 3000719653-2026-00003
• Device Sequence Number: 18287590
• Product Code: OLO
• UDI-Device Identifier: M9461087570
• UDI-Public: M9461087570
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K253661
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2026

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
• Operator of Device: Health Professional
• Device Model Number: 108757
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown