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

Model Number	403001-05
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that when navigating the cup the version and abduction outputs were incorrect.The version of the cup and abduction were confirmed to be correct by the surgeon intraoperatively using c-arm.Once the product is returned, orthalign, inc.Will perform an investigation into the alleged accuracy issue.Orthalign is filing this mdr with an abundance of caution with the understanding of the potential harm that could be caused to the patient by an inaccurate device measurement.
Event or Problem Description
It was reported that when navigating the cup the version and abduction outputs were completely incorrect.The version of the cup and abduction were confirmed to be correct by the surgeon intraoperatively using c-arm.
Additional Manufacturer Narrative
A review of the device history record (dhr) was conducted.The device passed all manufacturing specifications prior to release.Orthalign, inc.Will continue to monitor this issue and take action if alert limits are exceeded.

• Brand Name: ORTHALIGN PLUS UNIT
• Common Device Name: NAVIGATION UNIT
• Manufacturer (Section D): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo CA 92656
• MDR Report Key: 10786293
• Report Number: 3007521480-2020-00013
• Device Sequence Number: 11795997
• Product Code: OLO
• UDI-Device Identifier: 00851977007901
• UDI-Public: 00851977007901
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: distributor,health profession
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2021

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: Health Professional
• Device Model Number: 403001-05
• Device Catalogue Number: 403001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 05/04/2021
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 06/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1