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

Model Number 403087-06

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 07/12/2022

Event Type  malfunction  

Event Description

It was reported that the surgeon positioned the cup per the technique.The first time cup was registered with no incident.The second time the cup was registered it started at a normal value but then quickly started to drift away to different values.The drift was likely 10 degrees of anteversion before the 30 second timer ended.The third time the drift was not present.

Manufacturer Narrative

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 root cause of the failure is a power failure within the navigation unit.The navigation unit was opened for inspection and it was found that one of the batteries had visible burn marks on the "positive" end, and the battery connector had burn marks as well.This can cause the unit to not perform as expected.There is no navigation log available for review.No fault could be found with the returned reference sensor 5 unit.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
• Type of Device: 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: 15200205
• MDR Text Key: 305616461
• Report Number: 3007521480-2022-00008
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00851977007888
• UDI-Public: 00851977007888
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200642
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/09/2022

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
• Device Operator: 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: 07/19/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1