MAUDE Adverse Event Report: Treace Medical Concepts, Inc. Nanoplasty System; Plate

Model Number	SK57
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/26/2026
Type of Reportable Event	Serious Injury

• Brand Name: Nanoplasty System
• Common Device Name: Plate
• Manufacturer (Section D): Treace Medical Concepts, Inc.; 100 palmetto park place; ponte vedra FL 32081
• Manufacturer (Section G): Treace Medical Concepts, Inc.; 100 palmetto park place; ponte vedra FL 32081
• Manufacturer Contact: artillia walker ; 100 palmetto park place; ponte vedra, FL 32081 ; +1(904)913-1020
• MDR Report Key: 50856501
• Report Number: 3011623994-2026-00245
• Device Sequence Number: 9508679
• Product Code: HRS
• UDI-Device Identifier: 00810111222464
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K251135
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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
• Operator of Device: Health Professional
• Device Model Number: SK57
• 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: 08/26/2026
• Initial Report FDA Received Date: 09/22/2026
• 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: Female