MAUDE Adverse Event Report: Treace Medical Concepts, Inc. LAPIPLASTY SYSTEM 1; Plate

Model Number	SK12
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	09/03/2026
Type of Reportable Event	Serious Injury

• Brand Name: LAPIPLASTY SYSTEM 1
• 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: 50914356
• Report Number: 3011623994-2026-00256
• Device Sequence Number: 12094823
• Product Code: HRS
• UDI-Device Identifier: 00810111221337
• 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: 2021
• 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): 09/28/2026

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 Expiration Date: 10/11/2024
• Device Model Number: SK12
• Device Lot Number: 38772
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2021
• 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 Age: 22 YR
• Patient Sex: Female