MAUDE Adverse Event Report: ORTHALIGN, INC. LANTERN SURGICAL ASSISTANT; SURGCAL NAVIGATION SYSTEM

Model Number	406000-02
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to orthalign for evaluation by an orthalign engineer.The returned navigation unit was tested wiht the returned reference sensor and an in-house bracket as a system.The system passed pairing, bt, calibration, femur and tibia registration testing with no issues.The navigation unit log was also reviewed.During investigation the numbers on the summary screen matched the values on the resection plant screen within 0.5 degrees on every attempt.The complaint is unable to be confirmed as the reported event was unable to be replicated with the returned devices.However, this issue has been seen in engineering investigations of this software version on other units.Thus, the root cause was determined to be the buzzer interfering wit the final registration values on the summary screen.It is possible the issue was present for the user but was not present during investigation due to environmental conidiation, handling, or use since the procedure.Orthalign will continue to monitor this issue and the next software updated will address the software anomaly associated with this issue.
Event or Problem Description
Femur registration was completed but the values on the summary screen on the next page did not match the registration values.The numbers changed when advancing to the registration screen.The case was completed with manual instrumentation.

• Brand Name: LANTERN SURGICAL ASSISTANT
• Common Device Name: SURGCAL NAVIGATION SYSTEM
• Manufacturer (Section D): ORTHALIGN, INC.; 153 technology; irvine CA 92618
• Manufacturer (Section G): ORTHALIGN, INC.; 153 technology; irvine CA 92618
• Manufacturer Contact: karyl haskell ; 153 technology; irvine, CA 92618
• MDR Report Key: 21576541
• Report Number: 3007521480-2025-00010
• Device Sequence Number: 12848797
• Product Code: OLO
• UDI-Device Identifier: 00810832031567
• UDI-Public: 00810832031567
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K200892
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/11/2025

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: 406000-02
• Device Catalogue Number: 406000-02
• Device Lot Number: 2412124LS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown