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

Model Number SK12

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Manufacturer Narrative

It was reported that after an initial bunion surgery all hardware was removed due to what the surgeon believed was an allergic reaction to the hardware.There was no confirmation of metal allergy.The device was not returned to the manufacturer 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 sterile kits were reviewed and no non-conformances or issues during the manufacture or release of the product were identified to date that could have contributed to what was reported.Based on the limited information available and unsuccessful attempts to obtain additional information, the most likely cause of the allergic reaction 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.No other patient outcomes were reported as a result of this event.The company will supplement this mdr as necessary and appropriate.

Event Description

It was reported that after an initial bunion surgery all hardware was removed due to what the surgeon believed was an allergic reaction to the hardware.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.

Manufacturer Narrative

Additional data: a2: date of birth: (b)(6) 1967.Age: 52 year(s).A3: patient sex: female.D4: model number: sk12.Unique identifier (udi) number: (b)(4).D9: device available for evaluation? yes.Returned to manufacturer? yes.Date returned to manufacturer: 09/22/2021.G3: date received by manufacturer: 09/22/2021.G6: type of report: 30-day, follow-up.Follow-up number: 1.H2: if follow-up, what type? additional information, device evaluation.H3: device evaluated by manufacturer? yes.Evaluation summary attached: yes.H6: type of investigation: 10.Investigation findings: 213.H10: the devices were returned to the manufacturer for evaluation.Analysis did not confirm any device failure.The device history records for the implants were reviewed and no issues during the manufacture or release of the product were identified to date that could have contributed to what was reported.

• 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
• MDR Report Key: 12440283
• MDR Text Key: 270337243
• Report Number: 3011623994-2021-00048
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K192504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/20/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: SK12
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2021
• Initial Date Manufacturer Received: 08/12/2021
• Initial Date FDA Received: 09/08/2021
• Supplement Dates Manufacturer Received: 09/22/2021
• Supplement Dates FDA Received: 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR