MAUDE Adverse Event Report: ORTHALIGN, INC. ORTHALIGN PLUS SYSTEM - REFERENCE SENSOR 5 HIP (RS5H); SURGICAL NAVIGATION SYSTEM

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 11/29/2021

Event Type  malfunction  

Event Description

It was reported that when we were doing a da hip procedure the final leg length and offset were very far off normal readings.The readings for leg length were 20mm longer and 41mm medial.I requested he start again to see if we got the same readings twice.We got the same readings two times in a row.No patient injury was reported.

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.

Manufacturer Narrative

The investigation was able to confirm the accuracy issue described by the initial report.The cause of the inaccuracy was linked to the reference sensor used.This report has been updated to reflect the product information for the reference sensor identified as the problem component.Root cause was unable to be identified.Orthalign will continue to monitor this issue and take action when alert limits are exceeded.

• Brand Name: ORTHALIGN PLUS SYSTEM - REFERENCE SENSOR 5 HIP (RS5H)
• Type of Device: SURGICAL NAVIGATION SYSTEM
• 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: 13122728
• MDR Text Key: 283137082
• Report Number: 3007521480-2021-00029
• 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: K171780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/20/2023

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
• Device Lot Number: 21018532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 12/01/2021
• Supplement Dates FDA Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2021
• 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