MAUDE Adverse Event Report: ORTHALIGN, INC. LANTERN SURGICAL ASSISSTANT; 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	10/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
When tibia registration was performed, it was set to varus, but there was a suspicion of valgus when visually observed.When the alignment was checked manually, it was clearly valgus.Tried tibial registration again, but the same issue occurred.Surgery was completed with kneealign.
Additional Manufacturer Narrative
At this time the device has not been returned for investigation by an orthalign engineer.If the device is returned, an investigation will be completed to confirm the complaint and establish a root cause if possible.A follow up report will be filed detailing the conclusions of the investigation.
Additional Manufacturer Narrative
The device was returned to orthalign for evaluation by an orthalign engineer.The complaint could not be confirmed as the returned device passed all functional testing.Possible root causes for the reported incident include user misinterpreting display angles, user being not properly trained on surgical technique, or excessive material on the ankle disrupted one of the malleolor registrations.Orthalign will continue to monitor similar events and take action if necessary.No further action required at this time.
Event or Problem Description
When tibia registration was performed, it was set to varus, but there was a suspicion of valgus when visually observed.When the alignment was checked manually, it was clearly valgus.Tried tibial registration again, but the same issue occurred.Surgery was completed with kneealign.The surgery was performed on the right leg.The complaint event was found before the lantern setting and the resection.

• 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, CA 92618
• MDR Report Key: 23469650
• Report Number: 3007521480-2025-00016
• Device Sequence Number: 15719997
• Product Code: OLO
• UDI-Device Identifier: 00810832031567
• UDI-Public: 00810832031567
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2026

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: 2504143LS
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2025
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown