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

Model Number	403087
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	10/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
In the previous case the reference sensor was left on during impaction.After that the numbers seemed "off".When the surgeon tried to use the reference sensor in the next case it would not pair with the navigation unit.
Additional Manufacturer Narrative
At this time, the device is expected to be returned to orthalign for investigation,but has not yet 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 wih an understanding of the patient harm that could be caused by device inaccuracy.
Additional Manufacturer Narrative
The device was returned to orthalign for evaluation.The investigation has been completed by an orthalign engineer.The complaint is confirmed and the reference sensor behavior was reproducible by the orthalign engineer.The root cause was foun to be a software issue.The navigation unit was also tested by the orthalign engineer, but in the case of the navigation unit the behavior was not reproducible and the root cause cannot be determined.Orthalign will continue to monitor this issue and take action when alert limits are exceeded.

• Brand Name: ORTHALIGN PLUS
• Common Device Name: SURGICAL NAVIGATION SYSTEM
• Manufacturer (Section D): ORTHALIGN, INC.; 120 colombia; suite 500; aliso viejo CA 92656
• Manufacturer (Section G): ORTHALIGN, INC.; 120 colombia; suite 500; aliso viejo CA 92646
• Manufacturer Contact: karyl haskell ; 120 colombia; suite 500; aliso veijo, CA 92646
• MDR Report Key: 18011916
• Report Number: 3007521480-2023-00016
• Device Sequence Number: 12581991
• Product Code: OLO
• UDI-Device Identifier: 00858704006589
• UDI-Public: 00858704006589
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K172462
• 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): 11/21/2023

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: 403087
• Device Catalogue Number: 403087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/06/2023
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown