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 Problems Reaction (2414); No Code Available (3191)

Event Date 01/28/2020

Event Type  Injury  

Manufacturer Narrative

It was reported that a patient appeared to be having an allergic skin reaction approximately three months after an initial bunion surgery was performed on (b)(6) 2019.The patient underwent allergy testing which indicated a contact allergies to nickel sulfate hexahydrate, 4-phenylenediamine base, and myroxylon pereirae resin.However, due to the source of the allergic skin reaction being unknown, the surgeon opted to remove all implanted hardware (tmc and non-tmc) in a revision surgery on (b)(6) 2020.Upon removal, all tmc hardware was intact and the intended bones were completely fused/healed.The device was not returned to the manufacturer for evaluation.The device history record was reviewed and no issues were identified during the manufacture and release of the device that could have contributed to what was reported.The tmc device is made from titanium alloy (ti-6al-4v eli) in compliance with astm f136.The tmc plating system instructions for use indicates the following: "patient sensitivity to implant materials should be considered and assessed prior to surgery." the company will supplement this mdr as necessary and appropriate.

Event Description

It was reported that due to what appeared to be a suspected allergic reaction, the surgeon opted to remove all implanted hardware (tmc and non-tmc) from a patient on (b)(6) 2020.No deficiencies or failures were alleged/found with any tmc device.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
• Manufacturer (Section G): TREACE MEDICAL CONCEPTS, INC.; 203 fort wade road, suite 150; ponte vedra, fl
• Manufacturer Contact: uriza shums ; 203 fort wade road, suite 150; ponte vedra, fl ; 3735940134
• MDR Report Key: 9794265
• MDR Text Key: 191578269
• Report Number: 3011623994-2020-00007
• 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: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/05/2022
• Device Model Number: SK14
• Device Lot Number: 19080013360
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2019
• 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
• Patient Age: 45 YR