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

Model Number 403001-08

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 04/12/2022

Event Type  malfunction  

Manufacturer Narrative

At this time the product has been returned for investigation.Once the investigation into the alleged accuracy issue is performed a follow up submission will be filed.With an abundance of caution this report is being filed with the understanding of the potential patient harm that could be caused to the patient by an inaccurate device measurement.

Event Description

It was reported that during cup positioning the read out of numbers seemed to be the opposite of what the surgeon was doing.They double checked that the correct side was selected and that the impactor adapter was facing the correct direction.No adverse event was reported.

Manufacturer Narrative

The investigation was not able to reproduce the alleged behavior, although the navigational logs did confirm the unexpected values reported by the user.While the root cause cannot be determined, it is suspected to be user error, as the failure event could only be replicated when the incorrect hip was selected by the orthalign engineer.

• Brand Name: ORTHALIGN PLUS UNIT
• Type of Device: NAVIGATION UNIT
• 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 ; 9497152424
• MDR Report Key: 15490171
• MDR Text Key: 306263833
• Report Number: 3007521480-2022-00012
• Device Sequence Number: 1
• Product Code: OLO
• UDI-Device Identifier: 00810832031369
• UDI-Public: 00810832031369
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200642
• 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

• Date FDA Received: 09/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 403001-08
• Device Catalogue Number: 403001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Other