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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 SK12
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Type  Injury  
Manufacturer Narrative
It was reported that after an initial bunion surgery all hardware was removed due to what the surgeon believed was an allergic reaction to the hardware.There was no confirmation of metal allergy.The device was not returned to the manufacturer 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 sterile kits were reviewed and no non-conformances or issues during the manufacture or release of the product were identified to date that could have contributed to what was reported.Based on the limited information available and unsuccessful attempts to obtain additional information, the most likely cause of the allergic reaction cannot be determined as it is unknown if the patient underwent allergy testing to confirm metal as the source.No facts suggest a causal relationship between the implantation/explantation of tmc devices and the patient's reaction.No other patient outcomes were reported as a result of this event.The company will supplement this mdr as necessary and appropriate.
 
Event Description
It was reported that after an initial bunion surgery all hardware was removed due to what the surgeon believed was an allergic reaction to the hardware.No additional information has been received to date confirming the patient has a metal allergy.No other patient outcomes were reported as a result of this event.
 
Manufacturer Narrative
Additional data: a2: date of birth: (b)(6) 1967.Age: 52 year(s).A3: patient sex: female.D4: model number: sk12.Unique identifier (udi) number: (b)(4).D9: device available for evaluation? yes.Returned to manufacturer? yes.Date returned to manufacturer: 09/22/2021.G3: date received by manufacturer: 09/22/2021.G6: type of report: 30-day, follow-up.Follow-up number: 1.H2: if follow-up, what type? additional information, device evaluation.H3: device evaluated by manufacturer? yes.Evaluation summary attached: yes.H6: type of investigation: 10.Investigation findings: 213.H10: the devices were returned to the manufacturer for evaluation.Analysis did not confirm any device failure.The device history records for the implants were reviewed and no issues during the manufacture or release of the product were identified to date that could have contributed to what was reported.
 
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Brand Name
LAPIPLASTY SYSTEM
Type of Device
PLATE
Manufacturer (Section D)
TREACE MEDICAL CONCEPTS, INC.
203 fort wade road, suite 150
ponte vedra FL 32081
MDR Report Key12440283
MDR Text Key270337243
Report Number3011623994-2021-00048
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
PMA/PMN Number
K192504
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/20/2021
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
Device Model NumberSK12
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/22/2021
Initial Date Manufacturer Received 08/12/2021
Initial Date FDA Received09/08/2021
Supplement Dates Manufacturer Received09/22/2021
Supplement Dates FDA Received10/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age52 YR
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