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

Model Number	401612
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Unspecified Vascular Problem (4441)
Date of Event	03/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device in question in not available for return.Therefore, orthalign cannot confirm the complaint, and no root cause can be determined.The complaint reported that a pin from another manufacturer was used and may have contributed to the serious injury.Using a pin from a different manufacturer adjacent to orthalign instrumentation is considered off-label use and is cautioned against in the instructions for use.No further action required.
Event or Problem Description
Patient suffered a popliteal artery injury during the operation.He was transferred to (b)(6) hospital and confirmed the cause with his then primary surgeon.The surgeon predicted that the persona pin might have penetrated the tibia.

• 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: 21894795
• Report Number: 3007521480-2025-00011
• Device Sequence Number: 12802456
• Product Code: OLO
• UDI-Device Identifier: 00858704006329
• UDI-Public: 00858704006329
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/23/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 401612
• Device Catalogue Number: 401612
• 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: 03/26/2025
• Initial Report FDA Received Date: 04/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Unknown