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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VILEX IN TENNESSEE, INC. VILEX IMPLANT
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VILEX IN TENNESSEE, INC. VILEX IMPLANT Back to Search Results
Model Number UNKNOWN
Device Problem Break (1069)
Patient Problem Failure of Implant (1924)
Event Date 08/29/2017
Event Type  malfunction  
Manufacturer Narrative
As of this date 11/10/2017, vilex has not received any additional information from the sales rep or the doctor regarding the malfunction of this implant.
 
Event Description
Vilex contacted the sales rep by phone august 29th and 30th.Sales rep stated it was dr.(b)(6) who had a patient with an implant that has been implanted for about 2 years and the implant was now broken in the toe and had not been removed.Vilex emailed the sales rep again asking for an issue review form to be completed on august 30, 2017.On september 8, 2017 vilex asked sales rep to please give more information and complete the form.On september 8, 2017, sales rep submitted the form, containing very little information, reporting a lesser met hemi was broken.At the time of this report, this is all the known information that vilex has acquired.A supplemental report will be filed should vilex receive more information regarding this incident.
 
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Brand Name
VILEX IMPLANT
Type of Device
VILEX IMPLANT
Manufacturer (Section D)
VILEX IN TENNESSEE, INC.
111 moffitt street
mcminnville TN 37110
Manufacturer Contact
sylvia southard
111 moffitt street
mcminnville, TN 37110
9314747550
MDR Report Key7034804
MDR Text Key93133803
Report Number1051526-2017-00001
Device Sequence Number1
Product Code KWD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Other
Type of Report Initial
Report Date 11/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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