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

Model Number	403001-08-US
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Surgeon reported that the measurement for the tibial cut was incorrect.The procedure was completed with standard instrumentation and no impact to patient.
Additional Manufacturer Narrative
At this time the device has been returned to orthalign for evaluation.The investigation will be completed by an orthalign engineer to confirm the reported malfunction and determine the root cause.Once the investigation is complete a follow up report will be filed detailing the conclusions.This report is being filed out of an abundance of caution and with the understanding of the patient harm that could be caused by an incorrect cut.
Additional Manufacturer Narrative
The reference sensor was returned to orthalign for evaluation by an orthalign engineer and an investigation has been completed.The complaint is not confirmed and a root cause could not be established.The reference sensor passed all funcctional testing with not issues, including testing as a system with the navigation unit.The reported issue could not be replicated and the navigation unit logs showed no signs of incorrect measurement or other abnormalities.No further action necessary at this time.
Event or Problem Description
Surgeon reported that the measurement for the tibial cut was incorrect.The procedure was completed with standard instrumetnation and no impact to patient.

• Brand Name: ORTHALIGN PLUS SYSTEM
• Common Device Name: SURGICAL NAVIGATION SYSTEM
• Manufacturer (Section D): ORTHALIGN, INC.; 153 technology; irvine CA 92618
• Manufacturer (Section G): ORTHALIGN, INC.; 153 technology; irvine CA 92618
• Manufacturer Contact: karyl haskell ; 153 technology; irvine, CA 92618
• MDR Report Key: 20550147
• Report Number: 3007521480-2024-00017
• Device Sequence Number: 19605089
• Product Code: OLO
• UDI-Device Identifier: 00810832031987
• UDI-Public: 00810832031987
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K162962
• 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): 12/02/2024

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 Model Number: 403001-08-US
• Device Catalogue Number: 403001-08-US
• Device Lot Number: 2402050LS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown