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

Model Number	403087-06
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	09/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time the device has been returned to orthalign for investigation by an orthalign engineer, but the investigation has not yet been completed.Upon the completion of the investigation a follow up report will be filed detailing the conclusions, including root cause.This report is being filed out of an abundance of caution and with an understanding of the patient harm that could be caused by device inaccuracy.
Event or Problem Description
Version numbers kept drifting to zero throughout the case.No impact to patent.Case completed with conventional instruments.
Additional Manufacturer Narrative
The reference sensor was returned to orthalign for evaluation by an orthalign engineer and an investigation has been completed.The complaint is not confirmed and a root cause couldn't be established.The reference sensor passed all functional testing with no issues.The reported issue could not be replicated using proper technique.Orthalign attempted to retrieve the navigation unit used in the case, but it was not available so navigation logs related to the reported incident can not be reviewed.No further action necessary at this time.
Event or Problem Description
Version numbers kept drifting to zero throughout the case.No impact to patient.Case completed with conventional instruments.

• Brand Name: ORTHALIGN PLUS
• 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: 20505626
• Report Number: 3007521480-2024-00016
• Device Sequence Number: 18216613
• Product Code: OLO
• UDI-Device Identifier: 00851977007888
• UDI-Public: 00851977007888
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K171780
• 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 Assistant
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/02/2024

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: 403087-06
• Device Catalogue Number: 403087-06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/26/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 12/02/2024; 12/05/2024
• 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