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

Model Number	KA406000-02
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	12/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The values shown by the navigation unit do not match the actual values measured.The extension gap was confirmed by inserting a spacer block 10 mm (actual measurement 19 mm), and the gap was measured in extension and flexion with the lantern.The extension gap value (center value 7mm) and flexion gap value (center value 18mm) were indicated.The operation was completed with conventional instruments.
Additional Manufacturer Narrative
At this time the device is expected to be returned to orthalign for evaluation, but has not yet been received.Once received, the device will be evaluated by an orthalign engineer to attempt to confirm the complaint and determine a root cause.Upon completion of the investigation a follow up report will be filed detailing the conclusions.Orthalign will continue to monitor this type of event and at this time no further action is required.
Additional Manufacturer Narrative
The lantern navigation unit was returned for investigation, along with the lantern reference sensor, balance tibial paddle, balance femoral paddle, and torque driver.The navigation logs were downloaded and the reported numbers of 7mm extension and 18mm flexion were confirmed.The returned parts were tested individually and as a system.They passed all testing, including accuracy testing.The complaint is not confirmed and there is no indication that the returned devices contributed to system inaccuracy.The root cause was also unable to be determined.A possible root cause is the user misinterpreted the summary angles displayed.

• 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: 21021578
• Report Number: 3007521480-2024-00022
• Device Sequence Number: 9738884
• Product Code: OLO
• UDI-Device Identifier: 00810832031963
• UDI-Public: 00810832031963
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: KA406000-02
• Device Catalogue Number: KA406000-02
• Device Lot Number: 2402047LS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2024
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown