MAUDE Adverse Event Report: ORTHALIGN, INC. REFERENCE SENSOR 5 HIP REFERENCE SENSOR RS5H

Model Number 403087-06

Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); No Apparent Adverse Event (3189)

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

Event Date 09/13/2021

Event Type  malfunction  

Manufacturer Narrative

No fault could be found with the returned reference sensor 5h. 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. Orthalign will continue to monitor this issue and take action if or when alert limits are exceeded.

Event Description

It was reported that the unit doesn't work. The sensor was not providing accurate results. The cups version and abduction was just way off from the stated position.

• Brand Name: REFERENCE SENSOR 5 HIP
• 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: 12697624
• MDR Text Key: 278387524
• Report Number: 3007521480-2021-00026
• Device Sequence Number: 1
• Product Code: OLO
• 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,Distributor

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/11/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 403087-06
• Device Catalogue Number: 403087-06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown