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

Model Number	SK61
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that approximately two weeks after the initial bunion surgery on (b)(6) 2026, all hardware was removed and replaced during a revision surgery on (b)(6) 2026 due to a loose plate and non-compliance.There were no other patient outcomes reported as a result of this event.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.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 noncompliance.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 approximately two weeks after the initial bunion surgery on (b)(6) 2026, all hardware was removed and replaced during a revision surgery on (b)(6) 2026 due to a loose plate and non-compliance.There were no other patient outcomes reported as a result of this event.

• Brand Name: LAPIPLASTY SPEEDPLATE- MICROQUAD
• 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: artillia walker ; 100 palmetto park place; ponte vedra, FL 32081 ; 9049131020
• MDR Report Key: 25245384
• Report Number: 3011623994-2026-00128
• Device Sequence Number: 10501395
• Product Code: JDR
• UDI-Device Identifier: 00810111223638
• UDI-Public: (01)00810111223638(17)301209(10)300744838
• 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: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/21/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SK61
• Device Lot Number: 300744838
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2025
• 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 Sex: Unknown