MAUDE Adverse Event Report: VILEX, INC. VILEX CANNULATED MET HEAD IMPLANT

Model Number CMHI-16

Device Problem Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Type  Other  

Event Description

Apparent failure of a surgical procedure and/or implant.No further info received from doctor.

Manufacturer Narrative

On (b)(6) 2015, vilex received call from account manager of an apparent failure of a surgical procedure and/or implant.At this time, no further info has been received from doctor.Vilex will file supplemental report, should more info become available.

• Brand Name: VILEX CANNULATED MET HEAD IMPLANT
• Type of Device: MET HEAD IMPLANT
• Manufacturer (Section D): VILEX, INC.; mcminnville TN
• Manufacturer Contact: 111 moffitt street; mcminnville, TN 37110
• MDR Report Key: 4581260
• MDR Text Key: 17997580
• Report Number: 1051526-2015-00002
• Device Sequence Number: 1
• Product Code: KWD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Unknown
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 03/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CMHI-16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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 Sequence Number: 1