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

Model Number	406000-02
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
An expired navigation unit was used in a procedure.
Additional Manufacturer Narrative
At this time the device is not expected to be reuturned to orthalign for investigation.Three attempts were made to retrieve more information about the patient impact of the events and request the units be returned for evaluation.Orthalign can confirm the expiration date for the reported navigation unit is 8/31/2924 which confirms that it wa expired when used in the case on 10/8/2024.Therefore the complatin is confirmed.The root cause is determined to be user error.The expiration date is clearly visable on the packagaging and a review of manufacturing records confirms the reported device did not have any anomalies, including in labeling.The risk of using an expired device is the sterility of the unit is compromised which can lead to patient harms including infection and immune response.No patient harm was reported in this case.Additionally, orthalign approved a 2-year shelf life of the lantern navigation unit on 8/25/2024.The expired unit in this case was signed off for sterilization on 8/24/2023, one day before the expiration date was extended from one year to two years.At this time no additional action is required.

• Brand Name: LANTERN
• 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: 20610786
• Report Number: 3007521480-2024-00018
• Device Sequence Number: 7346555
• Product Code: OLO
• UDI-Device Identifier: 00810832031567
• UDI-Public: 00810832031567
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: 200892
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/05/2024

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: 406000-02
• Device Catalogue Number: 406000-02
• Device Lot Number: 2308124LS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown