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U.S. Department of Health and Human Services

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

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TREACE MEDICAL CONCEPTS, INC. LAPIPLASTY SYSTEM PLATE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Non-union Bone Fracture (2369)
Event Date 03/07/2022
Event Type  Injury  
Manufacturer Narrative
The devices were not returned to the manufacturer for evaluation. Non-conformance reports for all sks and sd20s were reviewed and no issues were identified during the manufacture and release of the device that could have contributed to what was reported. It was reported that after an initial bilateral bunion surgery, all hardware in one foot was removed in a revision surgery on (b)(6) 2022 due to non-union. The patient was revised with new tmc hardware. Upon removal, 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. Although a number of factors could have contributed to non-union of the patient's bones, based on feedback from the reporter, the non-union is likely a result of patient non-compliance following the initial surgery. The device is intended for fusion and non-union is a known potential adverse event identified in the instructions for use provided with the sterile kit, along with warnings related to postoperative care. The company will supplement the mdr as necessary and appropriate.
 
Event Description
It was reported that after an initial bilateral bunion surgery, all hardware in one foot was removed in a revision surgery on (b)(6) 2022 due to non-union. The patient was revised with new tmc hardware. Upon removal, 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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Brand NameLAPIPLASTY SYSTEM
Type of DevicePLATE
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
uriza shums
203 fort wade road, suite 150
ponte vedra, FL 32081
9043735940
MDR Report Key14018466
MDR Text Key288782812
Report Number3011623994-2022-00023
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K192504
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 04/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Date Manufacturer Received03/07/2022
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 Treatment Data
Date Received: 04/05/2022 Patient Sequence Number: 1
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