MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC; PLATE

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 10/28/2023

Event Type  Injury  

Event Description

It was reported that after initial bunion surgery on (b)(6) 2023, all hardware was removed on (b)(6) 2023 due to infection.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.

Manufacturer Narrative

It was reported that after initial bunion surgery on (b)(6) 2023, all hardware was removed on (b)(6) 2023 due to infection.The patient had undergone numerous tests for infection and infectious disease determined patient was having a reaction to the 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 information indicates the patient's bones were partially fused/healed.No devices were returned for evaluation.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.The most likely cause of the reported event could not be determined as the device was not returned for evaluation.However, the most likely cause is the patient's reaction to the hardware.There were no deficiencies or malfunctions alleged/found with any tmc device, nor were there any reported issues with placement of the device.The company will supplement this mdr as necessary and appropriate.

• Type of Device: 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: renae ginter ; 100 palmetto park place; ponte vedra, FL ; 9043735940
• MDR Report Key: 18196336
• MDR Text Key: 328887428
• Report Number: 3011623994-2023-00299
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention