MAUDE Adverse Event Report: ORTHALIGN ORTHALIGN PLUS; NAVIGATION UNIT

Model Number	403001
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); 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	07/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A customer experience report was submitted to orthalign from a regional sales manager stating that a navigation unit was showing inaccurate leg length information to the surgeon.The procedures were believe to have been properly executed.Orthalign fully expects to receive the navigation unit in question to investigate.At this point in time there is no information available to come to a conclusion as to what may have caused this inaccuracy.Orthalign is filing this medical device report with abundance of caution with the knowledge of how an inaccurate leg length reading has the potential to result in patient injury.When results of the investigation regarding the device in question is complete a follow up report will be filed.
Event or Problem Description
(b)(4).The unit was giving very inaccurate leg length.All procedures were believed to have been properly executed.
Additional Manufacturer Narrative
Despite multiple attempts, the device was not returned.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.

• Brand Name: ORTHALIGN PLUS
• Common Device Name: NAVIGATION UNIT
• Manufacturer (Section D): ORTHALIGN; 120 columbi; suite 500; aliso viejo CA 92656
• MDR Report Key: 8946198
• Report Number: 3007521480-2019-00020
• Device Sequence Number: 2585074
• 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: K172462
• 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): 06/07/2021

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: 03/31/2021
• Device Model Number: 403001
• Device Catalogue Number: 403001-05
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/01/2019
• Supplement Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1