MAUDE Adverse Event Report: ORTHALIGN, INC. KNEEALIGN 2; SURGICAL NAVIGATION SYSTEM

Model Number	133632
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, the surgeon questioned varus/valgus accuracy of femoral cut.Reporter was in the case and everything went as it should.The surgeon redid the move three times and kept getting the same result and he felt the 0.0 was cutting valgus into the cut.He then went to 1.0 varus to play on the safe side and proceeded to cut the femur and still felt it was cutting valgus into the femur.The case ended up good however he didn't like the femoral cut and was questioning the accuracy.Surgeon's other two cases today had no issues.[the surgeon] did not go and make a revision cut he continued with the procedure and made up for the valgus in other areas.
Additional Manufacturer Narrative
The device was returned to orthalign for evaluation by an orthalign engineer.The complaint was confirmed as the logs showed the customer approaching 0 deg v/v as reported.The returned device passed all functional testing.The root cause was determined to be misinterpretation of the oa+ system.Orthalign will continue to monitor similar events and take action if necessary.No further action required at this time.

• Brand Name: KNEEALIGN 2
• 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: 24241763
• Report Number: 3007521480-2026-00002
• Device Sequence Number: 18387637
• Product Code: OLO
• UDI-Device Identifier: 00858704006015
• UDI-Public: 00858704006015
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K163379
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 02/02/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 133632
• Device Catalogue Number: 133632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown