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U.S. Department of Health and Human Services

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

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TREACE MEDICAL CONCEPTS, INC. UNKNOWN LAPIPLASTY SYSTEM PLATE Back to Search Results
Model Number UNKNOWN
Device Problem Insufficient Information (3190)
Patient Problem Insufficient Information (4580)
Event Date 08/06/2021
Event Type  Injury  
Manufacturer Narrative
It was reported that after an initial right foot bunion surgery on (b)(6) 2020, an unknown quantity and combination of hardware was removed in a revision surgery on (b)(6) 2021. No device was returned for evaluation. The device history records for all possible lots were reviewed and no issues were identified during the manufacture and release of the devices that could have contributed to what was reported. Although a number of factors could have contributed to the removal of the hardware, based on the limited information available, the most likely cause of what was reported cannot be determined. No deficiencies or malfunctions have been confirmed/found with any tmc device. The company will supplement this mdr as necessary and appropriate.
 
Event Description
It was reported that after an initial right foot bunion surgery on (b)(6) 2020, an unknown quantity and combination of hardware was removed in a revision surgery on (b)(6) 2021. Due to limited information, no deficiencies/failures with any tmc hardware or other patient outcomes have been able to be confirmed.
 
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Brand NameUNKNOWN LAPIPLASTY SYSTEM
Type of DevicePLATE
Manufacturer (Section D)
TREACE MEDICAL CONCEPTS, INC.
203 fort wade road, suite 150
ponte vedra FL 32081 5159
Manufacturer (Section G)
TREACE MEDICAL CONCEPTS, INC.
203 fort wade road, suite 150
ponte vedra FL 32081 5159
Manufacturer Contact
jacklyn hayman
203 fort wade road, suite 150
ponte vedra, FL 32081-5159
9043735940
MDR Report Key14164636
MDR Text Key290974106
Report Number3011623994-2022-00032
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 04/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received03/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/20/2022 Patient Sequence Number: 1
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