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

Model Number	403001-05
Medical Device Problem Codes	Incorrect Measurement (1383); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An orthalign distributor reported that the second navigation unit that the surgeon attempted to use gave a flexion reading of 11 degrees.This was again an extreme angle that the surgeon knew was incorrect.Orthalign's representative noted that this particular surgeon has done hundres of cases and know this.Orthalign plus units have been cleared by the fda with the claim of +/- 3 degrees.This navigation unit was discarded after use.An investigation into the dhr for this device will be preformed and a follow up report will generated and submitted.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 or Problem Description
Navigation unit ((b)(4)) gave a flexion reading of 11 degrees, extreme.
Additional Manufacturer Narrative
A review of the design history file was performed by a trained orthalign, inc.Employee.The results of this review indicated that the device passed all manufacturing specifications prior to commercial release.The product was discarded after use and not returned to orthalign, inc.And therefore a failure analysis could not be performed and the complaint could not be confirmed.

• Brand Name: ORTHALIGN PLUS
• Common Device Name: NAVIGATION UNIT
• Manufacturer (Section D): ORTHALIGN INC.; 120 columbia; suite 500; aliso viejo CA 92656
• MDR Report Key: 8584229
• Report Number: 3007521480-2019-00011
• Device Sequence Number: 2319305
• Product Code: OLO
• UDI-Device Identifier: 00851977007901
• UDI-Public: 00851977007901
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K171780
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: 403001-05
• Device Catalogue Number: 403001-05
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention