MAUDE Adverse Event Report: ORTHALIGN, INC. LANTERN SURGICAL ASSISTANT; SURGICAL 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	02/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Navigation unit displayed 2.5 degress flexion on femur but then when advanced to next screen it showed 1 degree of flexion.
Additional Manufacturer Narrative
At this time the device has been requested to be returned to orthalign for evaluation by an orthalign engineer.If the device is returned an investigation will be performed to attempt to confirm the complaint and determine the root cause.A follow up report will be filed detailing the results of the investigation.
Additional Manufacturer Narrative
The navigation unit was returned to orthalign for investigation and tested with an in-house reference sensor and bracket.The system passed all testing and the numbers on the summary screen matched the values on the resection plane screen within 0.5 degrees on every attempt.The navigation unit logs were also downloaded and reviewed.The complaint is unable to be confirmed as neither the log file nor testing demonstrated the issue seen by the user.The root cause is also unable to be confimred but a potential root case is a software anomaly which has been seen during engineering investigation of production units where the buzzer interferes with the final registration values on the summary screen.It is possible this issue was present for the user in this navigation unit but no longer present during investigation due to environmental conditions, handling or use since the clinical procedure.
Event or Problem Description
Navigation unit displayed 2.5 degress flexion on femur but then when advanced to next screen it showed 1 degree of flexion.

• Brand Name: LANTERN SURGICAL ASSISTANT
• Common Device Name: SURGICAL 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: 21525997
• Report Number: 3007521480-2025-00008
• Device Sequence Number: 9560385
• 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,Followup
• Report Date (Section B): 04/16/2025

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: 2412123LS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 04/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown