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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 Problem Skin Inflammation/ Irritation (4545)
Event Date 10/31/2023
Event Type  Injury  
Manufacturer Narrative
It was reported that after an initial bunion surgery, all hardware was removed on 10-31-2023 due to irritation.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.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.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.Additional tmc device explanted in the same revision surgery was reported in mdr 3011623994-2023-00304.
 
Event Description
It was reported that after an initial bunion surgery, all hardware was removed on 10-31-2023 due to irritation.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.
 
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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 Key18235070
MDR Text Key329315850
Report Number3011623994-2023-00301
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 11/29/2023
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 10/31/2023
Initial Date FDA Received11/29/2023
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 Age52 YR
Patient SexFemale
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