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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EXACTECH, INC. VANTAGE TIBIAL PLATE FB SZ 3 RT

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EXACTECH, INC. VANTAGE TIBIAL PLATE FB SZ 3 RT Back to Search Results
Catalog Number 350-12-03
Device Problem Insufficient Information (3190)
Patient Problems Cyst(s) (1800); No Code Available (3191)
Event Date 01/31/2019
Event Type  Injury  
Manufacturer Narrative

Pending evaluation.

 
Event Description

Index surgery: (b)(6) 2018. Surgical management on right ankle arthrotomy, with removal of distal tibial cyst and bone grafting. The case report form indicates this event is possibly related to devices and unlikely related to procedure. This event report was received through clinical data collection activities.

 
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Brand NameVANTAGE
Type of DeviceTIBIAL PLATE FB SZ 3 RT
Manufacturer (Section D)
EXACTECH, INC.
2320 nw 66 court
gainesville FL 32653
Manufacturer (Section G)
EXACTECH, INC.
2320 nw 66th court
gainesville FL 32653
Manufacturer Contact
kate jacobson
2320 nw 66th court
gainesville, FL 32653
3523771140
MDR Report Key8451134
MDR Text Key139805858
Report Number1038671-2019-00183
Device Sequence Number1
Product Code HSN
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
Type of Report Initial,Followup
Report Date 11/12/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/26/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device Catalogue Number350-12-03
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2019
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: 03/26/2019 Patient Sequence Number: 1
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