MAUDE Adverse Event Report: ORTHALIGN, INC. ORTHALIGN PLUS; REFERENCE SENSOR

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	11/03/2020
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 units have caused in accurate readings.The surgeon was unable to navigate the cup.We are unsure of which unit have been causing the issue.
Additional Manufacturer Narrative
An investigation of the returned reference sensor was performed.The reference sensor was tested with an in-house navigation unit and able to pair with and complete back-table calibration several times without any issues.The device was found to function as designed.A review of the device history record (dhr) for the returned reference sensor 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.Correction to the 510(k) number included in this follow-up.

• Brand Name: ORTHALIGN PLUS
• Common Device Name: REFERENCE SENSOR
• Manufacturer (Section D): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo CA 92656
• MDR Report Key: 10936337
• Report Number: 3007521480-2020-00014
• Device Sequence Number: 3489642
• Product Code: OLO
• UDI-Device Identifier: 00851977007888
• UDI-Public: 00851977007888
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K200642
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2021

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: 403087-06
• Device Catalogue Number: 403087-06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 04/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1