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

Model Number	405204
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	08/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, the device is expected to be returned to orthalign for investigation but has not been received.If the device is received, an investigation will be performed to confirm the problem and determine the root cause, and a follow-up report will be filed detailing the conclusions.This report is being filed out of an abundance of caution and with an understanding of the patient harm caused by this issue.
Event or Problem Description
The lantern unit's accuracy was called into question for the femoral cut.The surgeon corrected intra-operatively.

• Brand Name: LANTERN SURGICAL ASSISSTANT
• 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 92618
• MDR Report Key: 22895835
• Report Number: 3007521480-2025-00015
• Device Sequence Number: 14948948
• Product Code: OLO
• UDI-Device Identifier: 00810832031451
• UDI-Public: 00810832031451
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 08/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 405204
• Device Catalogue Number: 405204
• 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: Not provided
• Initial Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown