MAUDE Adverse Event Report: THINK SURGICAL, INC TPLAN PLANNING STATION; SURGICAL PLANNING STATION

Model Number	109000
Medical Device Problem Codes	No Apparent Adverse Event (3189); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgical plan was made using the bks trimax implants rather than the bks cr implants requested by the surgeon.The or user noticed the difference in the implant model and notified the surgeon.The surgeon made the appropriate changes to reflect the correct implant and approved the plan.Changes were made before the case started.No delay and no patient harm.
Additional Manufacturer Narrative
The think surgical case planner preparing the template for this case, inadvertently selected the incorrect implant model, from menu displayed in tplan.The error was noticed prior to the surgery and corrected.No paitent injury reported and the surgery was completed successfully.Note: we noitced this event was not included in the maude database, and investigation discovered duplicate mdr number, (b)(4) initially submitted on 5/3/2024.Therefore, think surgical decided to submit this event under a new mdr number.

• Brand Name: TPLAN PLANNING STATION
• Common Device Name: SURGICAL PLANNING STATION
• 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: denise duchene ; 47201 lakeview blvd; fremont, CA 94538 ; 5102492300
• MDR Report Key: 20205948
• Report Number: 3000719653-2024-00008
• Device Sequence Number: 7650070
• Product Code: OLO
• UDI-Device Identifier: M9461090000
• UDI-Public: M9461090000
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K232802
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/12/2024

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: Other
• Device Model Number: 109000
• Device Catalogue Number: 109000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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