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

Model Number	403001
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A software bug was discovered on navigation units with software version (b)(4).After a verbal communication of this complaint was reported to orthalign staff.Swift action was taken to understand the impact of this software bug and the risks that needed to be considered.It was discovered that in the supine pathway only, if the user navigates to summary screen (navigation to this screen is optional), the app anteversion number will be displayed as zero degrees.The software bug does not impact the values shown during the navigation process - the software functions as designed during navigation.The orthalign navigation system is intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures.The system facilitates the accurate position of implants, relative to these alignment axes.These is no risk during the routine, indicated navigation process with the orthalign navigation units as the display of information during the navigation steps is accurate and is not affected by the software bug under review.When considering the risks that this bug poses in the surgical setting two were identified: an increased procedure time and the incorrect information of the information display.A review of the orthalign complaint database was conducted for the lots of navigation units manufactured with this software bug.This complaint is currently the only complaint orthalign has received and at this point the complaint rate is calculated as (b)(4).Based on the analysis that orthalign has completed the current complaint rate is within expected ranges as documented with in orthalign's product risk management file.A surgeon may question the orthalign software results when viewing the summary data which may cause action to revert to common navigational techniques of using x-ray navigation.Alternatively, a surgeon may choose to repeat the cup navigation steps to reaffirm navigated values.Either of these may lead to an increase in procedure but will still likely fall within an acceptable range based on orthalign risk analysis documents.The risks associated with that alternative are no different and no greater than the risk of the orthalign procedure.Orthalign is filing this mdr with an abundance of caution with the understanding that displaying incorrect information may cause an increased procedure time that may cause potential harm to the patient.
Event or Problem Description
As described by the initial reporter: "dr.(b)(6) had a case in which the summary screen displayed a 0.0 for the app anteversion value, which did not seem to match what he previously navigated to.(b)(6) provided notes to actual value recorded during procedure.".

• Brand Name: ORTHALIGN PLUS
• Common Device Name: NAVIGATION UNIT
• Manufacturer (Section D): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo CA 92656
• MDR Report Key: 9050734
• Report Number: 3007521480-2019-00021
• Device Sequence Number: 19268322
• Product Code: OLO
• UDI-Device Identifier: 00810832030072
• UDI-Public: 00810832030072
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K172462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/07/2019

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: 403001
• Device Catalogue Number: 403001-06
• Device Lot Number: UNKOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2019
• Initial Report FDA Received Date: 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1