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	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	12/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that after an initial bunion surgery all hardware was removed on (b)(6) 2025 due to nonunion.Additional information indicates the patient was non-compliant.The site was revised with non-tmc hardware.There were no deficiencies or malfunctions alleged/found with any tmc device and no other patient outcomes were reported as a result of this event.Device-specific information was not available; therefore, a review of device history records was not able to be performed.However, all non-conformances for possible kits utilized in surgery were reviewed and no non-conformances or issues during the manufacture or release of the products were identified to date that could have contributed to what was reported and no issues were identified during the manufacture and release of the devices that could have contributed to what was reported.The most likely cause of the reported event could not be determined as the device was not returned for evaluation.However, information received from the surgeon indicates the most likely cause is patient non-compliance.There were no deficiencies or malfunctions alleged/found with any tmc device, nor were there any reported issues with placement of the device or healing of the surgical site.The company will supplement this mdr as necessary and appropriate.
Event or Problem Description
It was reported that after an initial bunion surgery all hardware was removed on (b)(6) 2025 due to nonunion.Additional information indicates the patient was non-compliant.The site was revised with non-tmc hardware.There were no deficiencies or malfunctions alleged/found with any tmc device and no other patient outcomes were reported as a result of this event.
Additional Manufacturer Narrative
Additional information was received on 01/05/2025.Updated fields: b5.Describe event or problem: it was reported that after an initial bunion surgery on (b)(6) 2025 all hardware was removed on (b)(6) 2025 due to nonunion.Additional information indicates the patient was non-compliant.The site was revised with non-tmc hardware.There were no deficiencies or malfunctions alleged/found with any tmc device and no other patient outcomes were reported as a result of this event.D4.Additional device information: lot number: 44273.Expiration date (mm/dd/yyyy): 02/18/2030.Primary unique device identifier (udi) #: (b)(4).D6a.If implanted, give date (mm/dd/yyyy): (b)(6) 2025.G3.Date received by manufacturer (mm/dd/yyyy): 01/05/2025.G6: type of report: 30-day, follow-up (follow-up number 1).H2: if follow-up, what type: additional information.H4.Device manufacturer date (mm/dd/yyyy): 02/18/2025.H11: it was reported that after an initial bunion surgery on (b)(6) 2025 all hardware was removed on (b)(6) 2025 due to nonunion.Additional information indicates the patient was non-compliant.The site was revised with non-tmc hardware.There were no deficiencies or malfunctions alleged/found with any tmc device and no other patient outcomes were reported as a result of this event.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.The most likely cause of the reported event could not be determined as the device was not returned for evaluation.However, information received from the surgeon indicates the most likely cause is patient non-compliance.There were no deficiencies or malfunctions alleged/found with any tmc device, nor were there any reported issues with placement of the device or healing of the surgical site.The company will supplement this mdr as necessary and appropriate.
Event or Problem Description
It was reported that after an initial bunion surgery on (b)(6) 2025 all hardware was removed on (b)(6) 2025 due to nonunion.Additional information indicates the patient was non-compliant.The site was revised with non-tmc hardware.There were no deficiencies or malfunctions alleged/found with any tmc device and no other patient outcomes were reported as a result of this event.

• 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: uriza shums ; 100 palmetto park place; ponte vedra, FL 32081 ; 9043735940
• MDR Report Key: 23924952
• Report Number: 3011623994-2025-00142
• Device Sequence Number: 9029724
• Product Code: HRS
• UDI-Device Identifier: 00810111221337
• UDI-Public: (01)00810111221337(17)300218(10)44273
• 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: 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): 01/20/2026

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: SK12
• Device Lot Number: 44273
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: 01/05/2025
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/18/2025
• 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: 60 YR
• Patient Sex: Male