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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VILEX, INC. VILEX MINI MET HEAD
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VILEX, INC. VILEX MINI MET HEAD Back to Search Results
Model Number MMCI-13
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/28/2015
Event Type  malfunction  
Manufacturer Narrative
On (b)(6) 2015 - vilex received a call from a facility that the doctor explanted a broken mmci-13.The doctor was unaware of the date the device was implanted, when or how the implant broke.Vilex requested that the implant be returned.On 01/06/2016, vilex received the broken implant.Vilex's quality control department evaluated the implant and could not find a product flaw which would cause the breakage.Without more detailed info, vilex is unable to determine the cause of the breakage.After a review of vilex's complaint log, no other complaints were found against this device size.If more info should become available, a f/u report will be filed.
 
Event Description
Mini met head implant broke.
 
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Brand Name
VILEX MINI MET HEAD
Type of Device
MINI MET HEAD
Manufacturer (Section D)
VILEX, INC.
mcminnville TN 37110
Manufacturer Contact
111 moffitt street
mcminnville, TN 37110
9314747550
MDR Report Key5396698
MDR Text Key37234171
Report Number1051526-2016-00001
Device Sequence Number1
Product Code KWD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K070052
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/20/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMMCI-13
Device Lot Number4023
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/06/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/28/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/12/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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