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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VILEX, INC. FUZE INTRAMEDUALLARY NAIL

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VILEX, INC. FUZE INTRAMEDUALLARY NAIL Back to Search Results
Model Number FZ120-200T-25
Device Problem Failure to Osseointegrate (1863)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/27/2018
Event Type  malfunction  
Manufacturer Narrative
Vilex received call on (b)(6) 2018, regarding a broken 12mm fuze. (b)(6) 2015 - 12mm fuze (fz120-200t-25) was implanted in patient. (b)(6) 2018, surgery was performed to have the broken implant removed and a fusion revision was completed. Based on x-rays and discussion with the doctor, this was a non-union and the patient walked on it until it broke. A review of complaints was completed and none were found on any size of the 12mm fuze. A review of non-conformances was completed and none were found on this item, fz120-200t-25, lot 7018. If any additional information becomes available, vilex will file a supplemental report.
 
Event Description
Fuze nail broke.
 
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Brand NameFUZE INTRAMEDUALLARY NAIL
Type of DeviceFUZE
Manufacturer (Section D)
VILEX, INC.
111 moffitt street
mcminnville 37110
Manufacturer (Section G)
VILEX, INC.
111 moffitt street
mcminnville 37110
Manufacturer Contact
sylvia southard
111 moffitt street
mcminnville, TN 37110
9314747550
MDR Report Key8201210
MDR Text Key131714196
Report Number1051526-2018-00007
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K102413
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 12/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFZ120-200T-25
Device Catalogue NumberFZ120-200T-25
Device Lot Number7018
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/27/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/09/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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