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

Model Number 403087

Device Problem No Apparent Adverse Event (3189)

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

Event Date 05/27/2019

Event Type  malfunction  

Manufacturer Narrative

An orthalign distributor reported that during a total hip arthroplasty there was a malfunction with the reference sensor.An investigation will be preformed once the reference sensor 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.A follow up report will be filed with the investigation findings.

Event Description

It was reported that total hip arthroplasty was performed with hipalign.Surgeon installed a cup to the patient hip with impactor connected to the reference sensor.However, angle of the cup was shown abnormally after the cup installation.Subsequently, conventional method was used to complete the procedure.

Manufacturer Narrative

No fault could be found with the returned reference sensor, rs s/n: (b)(6).The reference sensor passed all visual and functional tests.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 if 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
• MDR Report Key: 8759815
• MDR Text Key: 190384091
• Report Number: 3007521480-2019-00013
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00858704006589
• UDI-Public: 00858704006589
• 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: 07/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 403087
• Device Catalogue Number: 403087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Date Manufacturer Received: 12/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention