MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC. LAPIPLASTY SPEEDPLATE; STAPLE

Model Number	SK52
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cyst(s) (1800); Hypersensitivity/Allergic reaction (1907); Skin Inflammation/ Irritation (4545)
Date of Event	05/21/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that after an initial bunion surgery on (b)(6) 2024, all hardware was removed on (b)(6) 2025 due to an adverse reaction to the hardware, resulting in prolonged inflammation around the surgical site and cyst formation.The cyst was removed with the hardware.No other patient outcomes were reported as a result of this event.Additional information indicates the patient's bones were completely fused/healed.No devices were returned for evaluation.The device history records were reviewed and no issues were identified during the manufacture and release of the devices that could have contributed to what was reported.Although several factors can contribute to the reported event, the most likely cause cannot be determined due to the limited information provided, and no device being returned.No deficiencies or malfunctions have been alleged/found with any tmc device.The company will supplement this mdr as necessary and appropriate.Additional tmc devices explanted in the same revision surgery were reported in 3011623994-2025-00060, 3011623994-2025-00061.
Event or Problem Description
It was reported that after an initial bunion surgery on (b)(6) 2024, all hardware was removed on (b)(6) 2025 due to an adverse reaction to the hardware, resulting in prolonged inflammation around the surgical site and cyst formation.No deficiencies or malfunctions were alleged/found with any tmc device, and no other patient outcomes were reported as a result of this event.
Additional Manufacturer Narrative
B4.Date of this report: 23-jul-2025.G3.Date received by manufacturer: 23-jul-2025.G6.Type of report: 30-day, follow-up 1.H6.Adverse event problem: investigation conclusions: 4310 (cause traced to non-device related factors).H11.The surgeon has not provided the patient's current status.Results from testing of the cyst and some tissues did not lead to a specific cause for the cyst or what the patient experienced.There were no metal allergies identified and no deficiencies or malfunction with the hardware.The patient is petite, so she could feel the cyst and it was very noticeable.The surgeon believes that due to its size, the cyst is the cause of what the patient experienced but is unsure as to what caused the cyst.The company will supplement this mdr as necessary and appropriate.

• Brand Name: LAPIPLASTY SPEEDPLATE
• Common Device Name: STAPLE
• 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: uriza shums ; 100 palmetto park place; ponte vedra, FL 32081 ; 9043735940
• MDR Report Key: 22216722
• Report Number: 3011623994-2025-00062
• Device Sequence Number: 15491041
• Product Code: JDR
• UDI-Device Identifier: 00810111221764
• UDI-Public: (01)00810111221764(17)290215(10)300524783
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K243658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2025

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
• Operator of Device: Health Professional
• Device Model Number: SK52
• Device Lot Number: 300524783
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2024
• 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