MAUDE Adverse Event Report: ORTHALIGN, INC. ORTHALIGN PLUS SYSTEM; REFERENCE SENSOR RS5H

Model Number 403087-06

Device Problem No Apparent Adverse Event (3189)

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

Event Date 12/16/2019

Event Type  malfunction  

Manufacturer Narrative

This initial report is being filed after the due date as the initial submission was found to have not be received during an attempt to submit the follow-up report.At that time, the error message "error: initial report / prior supplement has not been received.The initial report is missing." alerted orthalign inc of the issue prompting the submission of this as an initial report.A review of the device history record (dhr) was conducted.The device passed all manufacturing specifications prior to release.No fault could be found with the returned reference sensor.Orthalign, inc.Will continue to monitor this issue and take action when/if alert limits are exceeded.

Event Description

While performing the acetabular navigation the surgeon;s cup reading was 22/13 after using xray validation he felt thathis numbers were closer to 40/13.

• Brand Name: ORTHALIGN PLUS SYSTEM
• Type of Device: REFERENCE SENSOR RS5H
• 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: 12301633
• MDR Text Key: 265851239
• Report Number: 3007521480-2021-00020
• 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: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 403087-06
• Device Catalogue Number: 403087-06
• Date Manufacturer Received: 12/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/13/2018
• 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