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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TREACE MEDICAL CONCEPTS, INC. LAPIPLASTY SYSTEM 2 PLATE

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TREACE MEDICAL CONCEPTS, INC. LAPIPLASTY SYSTEM 2 PLATE Back to Search Results
Model Number SK14
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Swelling (2091)
Event Date 05/27/2020
Event Type  Injury  
Manufacturer Narrative
It was reported that approximately 7 months after an initial bunion surgery, all hardware was removed in a revision surgery on (b)(6) 2020 due to what the patient believed was causing nerve irritation and medial swelling. Upon removal, the surgeon found no failure with any of the hardware and indicated the initial correction appeared "perfect" with the intended bones completely fused/healed. Although the surgeon stated that the implanted hardware was not a contributing factor to what the patient was experiencing, he was unable to determine the source/cause of the nerve irritation and medial swelling. The hardware was removed along with adding amniotic graft tissue to the incision site to aid in post-surgical healing. There were no deficiencies or malfunctions alleged/found with any tmc device, nor were there any issues with placement of the device or healing of the surgical site. The surgeon stated the patient reported the site is currently still swollen, but otherwise is "much improved". The device was not returned to the manufacturer for evaluation, as it was discarded. Device specific product and lot information was not available, therefore a review of device history records was not able to be performed. However, all non-conformances for lapiplasty system 2 (sk14) 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. The company will supplement this mdr as necessary and appropriate.
 
Event Description
It was reported that approximately 7 months after an initial bunion surgery, all hardware was removed in a revision surgery on (b)(6) 2020 due to what the patient believed was causing nerve irritation and medial swelling. Upon removal, the surgeon found no failure with any of the hardware and indicated the initial correction appeared "perfect" with the intended bones completely fused/healed. Although the surgeon stated that the implanted hardware was not a contributing factor to what the patient was experiencing, he was unable to determine the source/cause of the nerve irritation and medial swelling. The hardware was removed along with adding amniotic graft tissue to the incision site to aid in post-surgical healing. There were no deficiencies or malfunctions alleged/found with any tmc device, nor were there any issues with placement of the device or healing of the surgical site. The surgeon stated the patient reported the site is currently still swollen, but otherwise is "much improved".
 
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Brand NameLAPIPLASTY SYSTEM 2
Type of DevicePLATE
Manufacturer (Section D)
TREACE MEDICAL CONCEPTS, INC.
203 fort wade road, suite 150
ponte vedra, fl
Manufacturer (Section G)
TREACE MEDICAL CONCEPTS, INC.
203 fort wade road, suite 150
ponte vedra, fl
Manufacturer Contact
uriza shums
203 fort wade road, suite 150
ponte vedra, fl 
3735940134
MDR Report Key10195433
MDR Text Key197975327
Report Number3011623994-2020-00012
Device Sequence Number1
Product Code HRS
UDI-Device Identifier00853114006051
UDI-Public00853114006051
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 distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 06/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberSK14
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/28/2020
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: 06/25/2020 Patient Sequence Number: 1
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