MAUDE Adverse Event Report: ORTHALIGN INC. ORTHALIGN PLUS; NAVIGATION UNIT

Model Number 403001-04

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/08/2019

Event Type  malfunction  

Manufacturer Narrative

An orthalign distributor reported that during a total hip arthroplasty there was a malfunction with the navigation unit.While performing the cup implantation the accuracy of the navigation unit was off by 7 degrees.Orthalign plus units have been cleared by the fda with the claim of +/- 3 degrees.An investigation will be preformed once the unit is returned from orthalign inc.'s distributor in (b)(4).With an abundance of caution this report is being filed with the understanding of the potential patient harm that could result from an accuracy malfunction of 7 degrees.A follow up report will be filed with the investigation findings.

Event Description

It was reported that a navigation unit prepared for total hip arthroplasty was performed with orhalign plus navigation.After cup installation, the unit display suddenly became black and the display went back to opening screen.Also, after preliminary cup fixation, the surgeon found actual angle showed in x-ray was different from the angle the navigation showed.(7 degrees) preliminary cup fixation: abduction 40 degree.X-ray photo: abduction 33 degree.

Manufacturer Narrative

The product was not returned for evaluation by orthalign and thus the initial report cannot be confirmed.The product's serial number was given to orthalign and device history record review was performed.This device passed all manufacturing specifications prior to release.Without product a failure analysis could not be performed.No further information was made available to orthalign and the investigation has been closed.If the product is ever returned to orthalign a subsequent report will be filed.

• Brand Name: ORTHALIGN PLUS
• Type of Device: NAVIGATION UNIT
• Manufacturer (Section D): ORTHALIGN INC.; 120 columbia; suite 500; aliso viejo CA 92656
• MDR Report Key: 8512163
• MDR Text Key: 146351879
• Report Number: 3007521480-2019-00009
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00851977007734
• UDI-Public: 00851977007734
• Combination Product (y/n): N
• PMA/PMN Number: K172462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 03/23/2020

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: 403001-04
• Device Catalogue Number: 403001-04
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/14/2019
• Initial Date FDA Received: 04/13/2019
• Supplement Dates Manufacturer Received: 03/14/2019
• Supplement Dates FDA Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention