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

Model Number 403001-05

Device Problem No Apparent Adverse Event (3189)

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

Event Date 04/08/2019

Event Type  malfunction  

Manufacturer Narrative

An orthalign distributor reported that the first navigation unit that the surgeon attempted to use gave a flexion reading of 18 degrees. The surgeon noted that this is extreme and it is unable to have traveled that much. Orthalign's representative noted that this particular surgeon has done hundreds of cases and know this. 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 the field. 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 this magnitude. A follow up report will be filed with the investigation findings.

Event Description

Navigation unit ((b)(4)) gave a flexion reading of 18 degrees, this is extreme and unable to travel that much.

• Brand Name: ORTHALIGN PLUS
• 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 ; 9202546370
• MDR Report Key: 8584230
• MDR Text Key: 146352890
• Report Number: 3007521480-2019-00010
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/31/2020
• Device Model Number: 403001-05
• Device Catalogue Number: 403001-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 05/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 05/06/2019 Patient Sequence Number: 1