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

Model Number	403001
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	09/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, the device is expected to be returned to orthalign for investigation, but has not yet been received.If the device is received, an investigation will be performed to confirm the problem and determine the root cause, and a follow-up report will be filed detailing the conclusions.This report is being filed out of an abundance of caution and with an understanding of the patient harm that could be caused by device inaccuracy.
Event or Problem Description
Everything calibrated fine, but the cut on the femur was significantly off.The surgery was completed with standard instruments.
Additional Manufacturer Narrative
The device was returned to orthalign for evaluation.The investigation has been completed by an orthalign engineer.The navigation unit passes all testing without issue.The complaint was confirmed but the behavior was not reproducable by the orthalign enginner and therefore, root cause cannot be established.Orthalign will continue to monitor this issue and take action when alert limits are excceded.

• Brand Name: ORTHALIGN PLUS
• Common Device Name: SURGICAL NAVIGATION SYSTEM
• Manufacturer (Section D): ORTHALIGN, INC.; 120 colombia; suite 500; aliso viejo CA 92656
• Manufacturer (Section G): ORTHALIGN, INC.; 120 colombia; suite 500; aliso viejo CA 92646
• Manufacturer Contact: karyl haskell ; 120 colombia; suite 500; aliso viejo, CA 92646
• MDR Report Key: 17920461
• Report Number: 3007521480-2023-00015
• Device Sequence Number: 12463673
• Product Code: OLO
• UDI-Device Identifier: 00858704006534
• UDI-Public: 00858704006534
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 403001
• Device Catalogue Number: 403001
• Device Lot Number: 23114535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/25/2023
• Supplement Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 10/12/2023
• Supplement Report FDA Received Date: 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Other; Required Intervention
• Patient Sex: Unknown