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

Model Number	405204
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Tibia measurements looked great, but was unable to get flexion numbers for the femur.Case was completed using the orthalign reference sensor for the tibia and standard instrumentation for the femur.
Additional Manufacturer Narrative
At this time, the device is expected to be returned to orthalign for investigation, but has not been recieved.If the device is recieved, 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 that could be caused by inaccurate measurement.
Additional Manufacturer Narrative
The device was returned to orthalign for evaluation.The investigation was completed by an orthalign engineer.The complaint was confirmed and the issue was able to be replicated.The root cause was deteremined to be the user failing to adequately pin the microblock for neutral alignment per the surgical technique guide.Orthingalign will continue to monitor this issue.No further action is necessary at this time.

• Brand Name: LANTERN SURGIAL 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: 19702853
• Report Number: 3007521480-2024-00010
• Device Sequence Number: 7785458
• Product Code: OLO
• UDI-Device Identifier: 00810832031451
• UDI-Public: 00810832031451
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 08/22/2024

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: 405204
• Device Catalogue Number: 405204
• 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: 06/27/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 08/23/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown