MAUDE Adverse Event Report: RESTOR3D, INC. KINOS AXIOM TOTAL ANKLE REPLACEMENT

Model Number	1801.1131
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Aseptic loosening (4883)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of production records reveals no nonconformance's associated with the production of the component in question.Patient factors are unable to be ruled out as a contributor to the event.Lack of production abnormalities indicates there was no device defect leading to the need for revision.
Event or Problem Description
It was reported that the patient had experienced loosening of the tibial implant of their total ankle replacement.

• Brand Name: KINOS AXIOM TOTAL ANKLE REPLACEMENT
• Common Device Name: TOTAL ANKLE REPLACEMENT
• Manufacturer (Section D): RESTOR3D, INC.; 4001 nc hwy 54; ste 3160; durham NC 27709
• Manufacturer (Section G): RESTOR3D, INC.
• Manufacturer Contact: brianna prindle ; 4001 nc hwy 54; ste 3160; durham, NC 27709
• MDR Report Key: 23730305
• Report Number: 3014833750-2025-00021
• Device Sequence Number: 18799546
• Product Code: HSN
• UDI-Device Identifier: 00850022178030
• UDI-Public: 00850022178030
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K192778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/05/2025

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
• Device Model Number: 1801.1131
• Device Lot Number: 2105003
• 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: 11/24/2025
• Initial Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2021
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown