MAUDE Adverse Event Report: OrthAlign, Inc. KneeAlign 2; Surgical Navigation System

Model Number	402042
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2026
Type of Reportable Event	Malfunction

• Brand Name: KneeAlign 2
• Common Device Name: Surgical Navigation System
• Manufacturer (Section D): OrthAlign, Inc.; 153 technology; irvine CA 92618
• Manufacturer (Section G): 153 Technology; 153 technology; irvine CA 92618
• Manufacturer Contact: karyl haskell ; 153 technology; irvine, CA 92618
• MDR Report Key: 50873810
• Report Number: 3007521480-2026-00011
• Device Sequence Number: 10715279
• Product Code: OLO
• UDI-Device Identifier: 00858704006336
• UDI-Public: 00858704006336
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K162962
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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
• Operator of Device: Health Professional
• Device Model Number: 402042
• Device Catalogue Number: 402042
• Device Lot Number: 25010901Z
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/31/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/22/2025
• Patient Sequence Number: 1
• Patient Sex: Unknown