MAUDE Adverse Event Report: ORTHALIGN, INC. ORTHALIGN PLUS SYSTEM; REFERENCE SENSOR 5

Model Number	403087
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time the product has not been returned for investigation.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 the patient could be subject to if the device produces inaccurate measurements.
Event or Problem Description
It was reported cup angle values were opposite/different than what was expected.Went through checklist of potential reasons, and all was done correctly.
Additional Manufacturer Narrative
The root cause according to the nav.Unit log file is most likely due to the rs5 sensor being unstable in communication check and the data received being abnormal.The navigation unit passed all related functional tests and functioned as designed when used during in-house functional testing with an in-house rs5.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 when/if alert limits are exceeded.

• Brand Name: ORTHALIGN PLUS SYSTEM
• Common Device Name: REFERENCE SENSOR 5
• Manufacturer (Section D): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo CA 92656
• MDR Report Key: 11904394
• Report Number: 3007521480-2021-00006
• Device Sequence Number: 3551167
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2021

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: No Information
• Device Model Number: 403087
• Device Catalogue Number: 403087-06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 05/28/2021
• Supplement Report FDA Received Date: 08/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization