MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC. LAPIPLASTY SYSTEM 2; PLATE

Model Number SK14

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body Reaction (1868)

Event Type  Injury  

Manufacturer Narrative

It was reported that after an initial bunion surgery on (b)(6) 2019, all hardware was removed in a revision surgery due to what the patient believed was her "body rejecting it." no additional information has been received to date confirming the patient has a metal allergy.No devices were returned to the manufacturer for evaluation.The device history records for all devices intended to be implanted were reviewed (1405-1410, 1405-1411, 1405-1408, 1405-1409, and 1405-4051) and no issues were identified during the manufacture and release of the devices that could have contributed to the problem reported.The other devices explanted in the same revision surgery were also tmc devices which were reported in mdrs 3011623994-2021-00055 and 3011623994-2021-00056.Based on the limited information available and unsuccessful attempts to obtain additional information, the most likely cause of what was reported cannot be determined as it is unknown if the patient underwent allergy testing to confirm metal as the source.No facts suggest a causal relationship between the implantation/explantation of tmc devices and the patient's reaction.The company will supplement the mdr as necessary and appropriate.

Event Description

It was reported that after an initial bunion surgery on (b)(6) 2019, all hardware was removed in a revision surgery due to what the patient believed was her "body rejecting it." no additional information has been received to date confirming the patient has a metal allergy.No other patient outcomes were reported as a result of this event.

• Brand Name: LAPIPLASTY SYSTEM 2
• Type of Device: PLATE
• Manufacturer (Section D): TREACE MEDICAL CONCEPTS, INC.; 203 fort wade road, suite 150; ponte vedra FL 32081
• Manufacturer (Section G): TREACE MEDICAL CONCEPTS, INC.; 203 fort wade road, suite 150; ponte vedra FL 32081
• Manufacturer Contact: julia white ; 203 fort wade road, suite 150; ponte vedra, FL 32081 ; 9043735940
• MDR Report Key: 12641782
• MDR Text Key: 277248092
• Report Number: 3011623994-2021-00054
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00853114006051
• UDI-Public: 00853114006051
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2022
• Device Model Number: SK14
• Device Lot Number: 26996
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2019
• 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