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

Model Number	SK50
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Pain (1994); Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	12/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after an initial bunion surgery on (b)(6) 2025, hardware was removed on (b)(6) 2025 due to nonunion and pain.The dorsal speedplate had backed out.There was no loss of correction and the patient only experienced pain when palpating dorsal side of foot.No other patient outcomes were reported as a result of this event.
Additional Manufacturer Narrative
It was reported that after an initial bunion surgery on (b)(6) 2025, hardware was removed on (b)(6) 2025 due to nonunion and pain.The dorsal speedplate had backed out.There was no loss of correction and the patient only experienced pain when palpating dorsal side of foot.The patient also had an asymptomatic nonunion, for which the surgeon prescribed vitamin d and a bone stimulator.No other patient outcomes were reported as a result of this event.An update from the surgeon indicated the patient is doing very well and very happy with the results.Removal of the two speedplates resolved the patient's dorsal pain.The surgeon was unable to determine the cause of the nonunion but attributed the dorsal pain to the backed out dorsal speedplate.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.A number of factors could have contributed to what was reported and although the most likely cause cannot be determined based on the available information and without return of the device, it is possible initial placement and/or post-operative activity of the patient led to loosening of the hardware.The company will supplement this mdr as necessary and appropriate.Additional tmc device explanted in the same revision surgery was reported in 3011623994-2025-00144.

• 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: 23929202
• Report Number: 3011623994-2025-00143
• Device Sequence Number: 15706347
• Product Code: JDR
• UDI-Device Identifier: 00810111221788
• UDI-Public: (01)00810111221788(17)300214(10)TM1405
• 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
• Report Date (Section B): 12/30/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: SK50
• Device Lot Number: TM1405
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2025
• 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: 61 YR
• Patient Sex: Female