MAUDE Adverse Event Report: ORTHALIGN, INC. KNEEALIGN2; SURGICAL NAVIGATION SYSTEM

Model Number	402045
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded at the hospital and was not returned to orthalign for evaluation.Therefore, the complaint cannot be confirmed and a definitive root cause cannot be determined.Orthalign documentation indicates reusable instruments must function as intended for at least five years of service.This device was used 11 years after its date of release.
Event or Problem Description
It was reported that when using knee align2 for bone cutting, the bone cutting guide appeared charred black, likely due to the oscillator blade striking it forcefully.The oscillator blade is other company's product.

• Brand Name: KNEEALIGN2
• 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: 23584312
• Report Number: 3007521480-2025-00017
• Device Sequence Number: 13138046
• Product Code: OLO
• UDI-Device Identifier: 00858704006350
• UDI-Public: 00858704006350
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103829
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/18/2025

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: 402045
• Device Catalogue Number: 402045
• Device Lot Number: 14090801HS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2014
• 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
• Patient Sex: Unknown