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

Model Number	406000-02
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Possible inaccurate measurement -- it was reported that the user (surgeon) did not trust the degrees of varus the device was reading for the distal femur.Believed that the numbers should have been for the opposite side but the unit was set to the correct side.
Additional Manufacturer Narrative
The lantern navigation unit involved in this case was received by orthalign for investigation on (b)(6) 2022.The behavior reported by the user could not be reproduced by the orthalign engineer.No fault could be found with the unit, and there was no indication in the log files that the problem described by the user existed.Since the accuracy of the femoral registrations is mostly dependent on the reference sensor, it is recommended that the reference sensor involved in the case be returned for further investigation.A full investigation log is attached.Despite the inability to confirm the complaint and no adverse event taking place, this report is being filed out of an abundance of caution due to the potential for patient harm that is presented by inaccurate device measurement.Note: this report is being submitted as an initial report outside of the required 30-day window due to a lapse in access to the fda electronic submissions gateway.After departure of a former employee, new esg accounts were requested starting in (b)(6) 2022, however, access to the production environment was delayed and still not received in time to submit the initial report within the 30-day window.Please see documentation attached.Orthalign will continue to monitor this issue and take action when alert limits are exceeded.

• Brand Name: LANTERN SURGICAL ASSISTANT
• Common Device Name: SURGICAL NAVIGATION SYSTEM
• Manufacturer (Section D): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo CA 92656
• Manufacturer (Section G): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo CA 92656
• Manufacturer Contact: karyl haskell ; 120 columbia; suite 500; aliso viejo, CA 92656
• MDR Report Key: 16402014
• Report Number: 3007521480-2023-00003
• Device Sequence Number: 11604166
• Product Code: OLO
• UDI-Device Identifier: 00810832031567
• UDI-Public: 00810832031567
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/17/2023

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: 2206003LS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2022
• Initial Report FDA Received Date: 02/20/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown