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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 Break (1069)
Patient Problems Pain (1994); No Code Available (3191)
Event Date 12/03/2018
Event Type  Injury  
Manufacturer Narrative

The device was not returned to the manufacturer for evaluation as it remains implanted with no revision scheduled at this time. The device history records for all devices intended to be implanted were reviewed (1405-1012, 1405-1014, and 1405-4005) and no issues were identified during the manufacture and release of the device that could have contributed to the problem reported. Based on the available information, one plate and two screws were found broken upon reviewing radiographic images from a postoperative follow-up. The root cause cannot be determined due the devices not being returned for evaluation and review of radiographic evidence was also inconclusive as to the likely cause. Although a number of factors could have contributed to the breakage of the plate and screws, it is possible loss of correction or patient non-compliance subjected excessive bending stresses which lead to their breakage. The instructions for use identify warnings related to postoperative care. The company will supplement the mdr as necessary and appropriate.

 
Event Description

After an initial bunion surgery on (b)(6) 2018, one plate and two screws were found broken upon review of radiographic images from the patients postoperative follow-up. The devices currently remain implanted with no revision scheduled at this time.

 
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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 Key8204975
MDR Text Key132223510
Report Number3011623994-2018-00056
Device Sequence Number1
Product Code HRS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK143717
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/05/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/28/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/07/2020
Device MODEL NumberSK12
Device LOT Number23876
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/08/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/05/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/30/2017
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: 12/28/2018 Patient Sequence Number: 1
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