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

Model Number	403001
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This initial report is being filed after the due date as the initial submission was found to have not been received during an attempt to submit the follow-up report.At that time, the error message "error: initial report / prior supplement has not been received.The initial report is missing." alerted orthalign inc of the issue prompting the submission of an initial report.
Event or Problem Description
Setting microblock was ok, quantity of osteotomy was very different from quantity the surgeon had planned.First fixation pins were re-inserted to retry the femur registration.However, surgeon was unable to complete the registration 20 times.After that, the navigation unit battery turned off and could not be rebooted.Subsequently, conventional instruments were used to complete the procedure.A review of the device history record (dhr) was conducted.The device passed all manufacturing specifications prior to release.The failure could not be reproduced.According to the navigation unit event log, the user repeatedly saw an inconsistent hip point error while attempting the femoral maneuver; this aspect of the complaint can be confirmed.This error can also occur if the system is unable to determine where the femoral head resides based on the maneuver performed.Orthalign, inc.Will continue to monitor this issue and take action when/if alert limits are exceeded.

• Brand Name: ORTHALIGN PLUS SYSTEM
• Common Device Name: ORTHALIGN PLUS NAVIGATION UNIT
• Manufacturer (Section D): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo CA 92656
• MDR Report Key: 12284411
• Report Number: 3007521480-2019-00024
• Device Sequence Number: 5098065
• Product Code: OLO
• UDI-Device Identifier: 00851977007734
• UDI-Public: 00851977007734
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2021

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: No Information
• Device Model Number: 403001
• Device Catalogue Number: 403001-04
• Device Lot Number: 356420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 08/05/2021
• Patient Sequence Number: 1