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

Model Number	403001-08
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	12/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon questioned the original flexion number of (10.5) as he thought it should have been closer to 3 degrees.Surgeon also questioned the slope and varus/valgus on the tibia (surgeon aims for 4/4.5 slope and 0/0.5 vaurs).The patient was a larger patient with a bigger bone structure and no severe deformities.
Additional Manufacturer Narrative
The device was returned to orthalign for evaluation by an orthalign engeineer.An investigation will be completed to confirm the complaint and establish a root cause if possible.A follow up report will be filed detailing the conclusions of the investigation.
Event or Problem Description
It was reported that the surgeon questioned the original flexion number of (10.5) as he thought it should have been closer to 3 degrees.Surgeon also questioned the slope and varus/valgus on the tibia (surgeon aims for 4/4.5 slope and 0/0.5 varus).The patient was a larger patient with a bigger bone structure and no severe deformities.
Additional Manufacturer Narrative
The device was returned to orthalign for evaluation by an orthalign engineer.The complaint could not be confirmed as the returned device passed all functional testing and provided consistent outputs.A root cause was not established as the investigation determined that the retured unit was proven to provide correct system outputs.Orthalign will continue to monitor similar events and take action if necessary.No further action required at this time.

• 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 92618
• MDR Report Key: 24125527
• Report Number: 3007521480-2026-00001
• Device Sequence Number: 9689672
• Product Code: OLO
• UDI-Device Identifier: 00810832031987
• UDI-Public: 00810832031987
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 02/05/2026

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
• Device Model Number: 403001-08
• Device Catalogue Number: 403001-08
• Device Lot Number: 2507194LS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/20/2026
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2025
• 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: Required Intervention
• Patient Sex: Unknown