MAUDE Adverse Event Report: restor3d, inc. Kinos TAR; Total Ankle Replacement

Model Number	1834-0141; 2833-1003; 3832-1306
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	02/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was determined during case intake that the patient was a return patient and had their implants removed and replaced with a cement spacer due to infection.
Additional Manufacturer Narrative
Follow-up with the surgeon revealed that infection led to removal of the implants.Review of production records reveals no abnormalities in the manufacture, packaging, or sterilization of the device that could increase the risk of infection.

• Brand Name: Kinos TAR
• 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.; 4001 nc hwy 54; ste 3160; durham NC 27709
• Manufacturer Contact: brianna gabbard ; 4001 nc hwy 54; ste 3160; durham, NC 27709
• MDR Report Key: 50288082
• Report Number: 3014833750-2026-00041
• Device Sequence Number: 9732511
• Product Code: HSN
• UDI-Device Identifier: 00840097509266
• UDI-Public: 00840097509266
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K232595
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2026

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: 1834-0141; 2833-1003; 3832-1306
• Device Lot Number: 2024110020;2024090039;24050053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2026
• Initial Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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