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

Model Number 403087

Device Problem Incorrect Measurement (1383)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/28/2021

Event Type  malfunction  

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 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.

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
• Type of Device: REFERENCE SENSOR 5
• Manufacturer (Section D): ORTHALIGN, INC.; 120 columbia; suite 500; aliso viejo CA 92656
• MDR Report Key: 11904394
• MDR Text Key: 266157279
• Report Number: 3007521480-2021-00006
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00810832030072
• UDI-Public: 00810832030072
• Combination Product (y/n): N
• PMA/PMN Number: K172462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization