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U.S. Department of Health and Human Services

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

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TREACE MEDICAL CONCEPTS, INC; PLATE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Skin Inflammation/ Irritation (4545)
Event Date 12/11/2023
Event Type  Injury  
Event Description
It was reported that after an initial bunion surgery in 2022, all hardware was removed on (b)(6) 2023 due to pain and irritation in the medial area of the foot.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 an initial bunion surgery in 2022, all hardware was removed on (b)(6) 2023 due to pain and irritation in the medial area of the foot.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 completely fused/healed.Per feedback from the surgeon, the patient had likely been too aggressive with the weight bearing protocol.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, per feedback from the surgeon, it is possible patient noncompliance could have contributed to what the patient experienced.There were no deficiencies or malfunctions alleged/found with any tmc device, nor were there any reported issues with placement of the device or healing of the surgical site.The company will supplement this mdr as necessary and appropriate.
 
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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 Key18490154
MDR Text Key332601970
Report Number3011623994-2024-00011
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/10/2024
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
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/11/2023
Initial Date FDA Received01/10/2024
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 Number1
Patient Outcome(s) Required Intervention;
Patient Age68 YR
Patient SexFemale
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