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	12/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the device was disposed of at the hospital and is therefore not expected to be returned for investigation by an orthalign engineer.A follow up report will be filed if the part is returned.This issue will continue to be monitior, however no further action is required at this time.
Event or Problem Description
Surgeon was having difficulty with the navigation reading tas needing less flexion.
Additional Manufacturer Narrative
The device was disposed of at the hospital and is unable to be returned to orthalign for evaluation.Therefore, the complaint is unable to be verified and a definitve root cause can not be deteremined.Based on the complaint description a possible root cause is poor placement of the instrument pins.Orthalign cannot confirm whether or not the device functioned as intended.No further action is required.
Event or Problem Description
Surgeon was having difficulty with the navigation reading as needing less flexion.A new unint was opened and used to complete the case.

• 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
• MDR Report Key: 21507202
• Report Number: 3007521480-2024-00021
• Device Sequence Number: 7902067
• Product Code: OLO
• UDI-Device Identifier: 00810832031567
• UDI-Public: 00810832031567
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/03/2025

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: 2407089LS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/05/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown