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	10/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that both sensors gave inverted/retroverted reading for the cup.The rep, staff and surgeon insist the cup adaptor was facing the correct position.
Additional Manufacturer Narrative
At this time there is no known injury to the patient.The device has been returned to orthalign therefore an investigation into the alleged accuracy issue will be performed and a follow-up report will be submitted.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.
Additional Manufacturer Narrative
No fault could be found with the returned reference sensor 5 unit.The reference sensor powered up and successfully passed horizontal, vertical, and side calibration.The sensor also successfully completed multiple simulated maneuvers during testing.The reference sensor was found to function as design.It is suspected that the user experienced inverse angle measurements by selecting the incorrect hip (i.E.Left/right) on the navigation unit during back table set up.By selecting the incorrect hip during set up, when the user has correctly performed the registrations and is measuring cup angle, the cup angle will show -40 degrees instead of 40 degrees as expected.There is no navigational log available for review, so this suspicion cannot be confirmed.A review of the device history record (dhr) 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: REFERENCE SENSOR
• Manufacturer (Section D): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo CA 92656
• Manufacturer (Section G): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo CA 92656
• Manufacturer Contact: karyl haskell ; 120 columbia; suite 500; aliso viejo, CA 92656
• MDR Report Key: 12830846
• Report Number: 3007521480-2021-00027
• Device Sequence Number: 19924472
• Product Code: OLO
• UDI-Device Identifier: 00851977007888
• UDI-Public: 00851977007888
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2022

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: 11/03/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2021
• Supplement Date Received by Manufacturer: 01/04/2022
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown