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

Model Number	403001-05
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	11/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time there is no known injury to the patient.Once the product is returned orthalign 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 total hip arthroplasty was performed with hipalign (als approach).The surgeon set that abduction angle was 40 degree with the navigation system.However, he found that the angle was different by from 10 to 15 degrees by image.Then, he impacted a cup in accordance with the image three times (the targeted abduction angle 40 degree) and the cup was installed.After that, angles the navigation showed were abduction 52 degrees and anteversion 25 degrees and abduction 50 degrees and anteversion 22 degrees.The installed cup angle was correct by the surgeon's postoperative evaluation.
Additional Manufacturer Narrative
The returned navigation unit and both reference sensors passed all visual and functional tests.A review of the event log indicated a significant change in navigation unit orientation between the initial measurement and secondary measurement.This could indicate that either the pelvis moved significantly, or the pelvic base moved significantly between registrations.The user should ensure the pelvic base does not move between registrations.A review of the device history record (dhr) for the returned orthalign plus unit was conducted.The device passed all manufacturing specifications prior to release.Orthalign will continue to monitor this issue and take action if or when alert limits are exceeded.

• 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: 10997058
• Report Number: 3007521480-2020-00020
• Device Sequence Number: 3823578
• Product Code: OLO
• UDI-Device Identifier: 00851977007901
• UDI-Public: 00851977007901
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: distributor,foreign,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2021

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: 403001-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Initial Date Received by Manufacturer: 11/11/2020
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 12/12/2020
• Supplement Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1