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

Model Number SK1?

Device Problem Biocompatibility (2886)

Patient Problems Local Reaction (2035); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

It was reported that after an initial bunion surgery on an unknown date, all hardware was removed from a patient who appeared to be having an allergic skin reaction to metal in a revision surgery also on an unknown date.The device was not returned to the manufacturer for evaluation and device specific lot information was not available, therefore all non-conformances for sk12 and sk14 kits were reviewed and no non-conformances or issues during the manufacture or release of the products were identified that could have contributed to what was reported.Based on the limited information provided, the most likely cause of the skin reaction cannot be determined as it is unknown if the patient underwent allergy testing to confirm metal as the source.However, no deficiencies or failures were alleged or have been found against any tmc device.Additional information obtained indicates the surgeon revised the site with bone graft and the current patient status was reported as healed and doing well.The company will supplement this mdr as necessary and appropriate.

Event Description

It was reported that all hardware was removed from a patient who appeared to be having an allergic skin reaction to metal.Additional information obtained indicates the surgeon revised the site with bone graft and the current patient status was reported as healed and doing well.There was no other report of any patient impact or injury as a result of this event.

• Brand Name: LAPIPLASTY SYSTEM
• 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: jacklyn hayman ; 203 fort wade road, suite 150; ponte vedra, FL 32081 ; 9043735940
• MDR Report Key: 9290155
• MDR Text Key: 165452918
• Report Number: 3011623994-2019-00047
• Device Sequence Number: 1
• Product Code: HRS
• 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: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SK1?
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2019
• 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