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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
Model Number 350-12-03
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bone Fracture(s) (1870)
Event Date 08/14/2020
Event Type  Injury  
Manufacturer Narrative

Pending evaluation. Concomitant device(s): 350-22-41, tibial insert fb sz 1 rt 10mm. 350-02-01, talar implant sz 1 rt.

 
Event Description

As reported, during a gastrocnemius-soleus recession under fluoroscopy procedure on this (b)(6) y/o female who is insulin dependent diabetic and has history of post traumatic arthritis, experienced a two part fracture of the medial malleolus occurred during the procedure, and was fixed with a hook plate and bone graft. Surgeon will follow up with an ae check after 3 months to determine if event is resolved. There are no devices to be returned. The clinical study case report form indicates this event is not related to devices and definitely 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 66 ct
gainesville FL 32653
Manufacturer Contact
kate jacobson
3523771140
MDR Report Key10458702
MDR Text Key204519345
Report Number1038671-2020-00506
Device Sequence Number1
Product Code HSN
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK152217
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 08/27/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/27/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number350-12-03
Device Catalogue Number350-12-03
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/18/2020
Was Device Evaluated By Manufacturer? No
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: 08/27/2020 Patient Sequence Number: 1
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