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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
Model Number SK1?
Device Problem Biocompatibility (2886)
Patient Problems Local Reaction (2035); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
It was reported that after an initial bunion surgery on an unknown date, all hardware was removed from a patient who appeared to be having an allergic skin reaction to metal in a revision surgery also on an unknown date. The device was not returned to the manufacturer for evaluation and device specific lot information was not available, therefore all non-conformances for sk12 and sk14 kits were reviewed and no non-conformances or issues during the manufacture or release of the products were identified that could have contributed to what was reported. Based on the limited information provided, the most likely cause of the skin reaction cannot be determined as it is unknown if the patient underwent allergy testing to confirm metal as the source. However, no deficiencies or failures were alleged or have been found against any tmc device. Additional information obtained indicates the surgeon revised the site with bone graft and the current patient status was reported as healed and doing well. The company will supplement this mdr as necessary and appropriate.
 
Event Description
It was reported that all hardware was removed from a patient who appeared to be having an allergic skin reaction to metal. Additional information obtained indicates the surgeon revised the site with bone graft and the current patient status was reported as healed and doing well. There was no other report of any patient impact or injury 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
jacklyn hayman
203 fort wade road, suite 150
ponte vedra, FL 32081
9043735940
MDR Report Key9290155
MDR Text Key165452918
Report Number3011623994-2019-00047
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 11/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSK1?
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/08/2019
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: 11/07/2019 Patient Sequence Number: 1
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