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

Model Number	402042
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time, the device is expected to be returned to orthalign for investigation, but has not yet been recieved.If the device is recieved, an investigation will be performed to confirm the problem and determin the root cause, and a follow-up report will be filed detailing the conclustions.This report is being filed out of an abundance of caution and with an understanding of the patient harm that could be caused by device inaccuracy.
Event or Problem Description
Microblock is loose and drops down during use.There was no impact to patient and the case was completed with the microblock and the rest of the orthalign navigation system.
Additional Manufacturer Narrative
The part was returned, but mistakenly disposed of before a physical investigation could be conducted.Video evidence provided by the user was reviewed, but the root cause could not be established from video review alone.This complains is unverified and it cannot be confirmed whether the device functioned as intended due to lack of physical part available for investigation.A possible root cause is wear from use cycles over time as the reported incident was 12 years after the release date for this part.
Event or Problem Description
Microblock is loose and drops down during use.The surgeon is uncertain where to measure.There was no impact to patient and the case was completed with the microblock and the rest of the orthalign navigation system.

• 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: 20279618
• Report Number: 3007521480-2024-00014
• Device Sequence Number: 12626048
• Product Code: OLO
• UDI-Device Identifier: 00858704006336
• UDI-Public: 00858704006336
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2025

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: 402042
• Device Catalogue Number: 402042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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