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

Model Number	403001-08-US
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time the device has been returned to orthalign for evaluation by an orthalign engineer.The complaint will be investigated and a follow up report will be filed including whether or not the complaint was confirmed and a root cause, if one could be identified.
Event or Problem Description
During the femoral maneuver multiple attempts were made to achieve registration.The numbers seemed off and the paddles did not align with the bone.The navigation unit was reproved and reset but the problem persisted.The procedure was completed with a second navigation unit and a second reference sensor.No injury, death, or increased tourniquet time.
Event or Problem Description
1st navigation unit and reference sensor (both returned) - after successful tibia registration, user failed to complete multiple femur maneuver attempts, eventually completing the maneuver with unsatisfactory results: - surgeon said response numbers were off (not within expected general range) - paddles did not align with the bone - cut block did not drop as expected - surgeon "removed all" and performed femur again with similar poor outcome 2nd navigation unit and reference sensor - successful femur alignment and cut.
Additional Manufacturer Narrative
The first navigation unit and reference sensor used were returned to orthalign for evaluation by an orthalign engineer.The paddles and cutting block were not returned.The returned devices were tested individually and as a system, and both devices exhibited issues with the femur maneuver.This femur manueuver malfuction portion of the complaint is confirmed.The navigation logs were reviewed and the reported numbers outside of the expected range were present, however, the unexpected numbers could not be reproduced during testing.Therefore, the accuracy portion of the complaint can not be confirmed.The root cause could not be determined.Portential root causes include user error, bad pinning, and instrument wear.Orthalign will continue to monitor complaint data and take action when necessary.No further action required.

• Brand Name: ORTHALIGN PLUS
• 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
• MDR Report Key: 21930020
• Report Number: 3007521480-2025-00006
• Device Sequence Number: 18305407
• Product Code: OLO
• UDI-Device Identifier: 00810832031987
• UDI-Public: 00810832031987
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2025

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: 2310013LS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown