MAUDE Adverse Event Report: IVOCLAR VIVADENT AG VARIOLINK VENEER; MATERIAL, TOOTH SHADE, RESIN

Catalog Number 591425AN

Device Problems Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Customer complained that the material did not polymerize properly when used with the bluephase style curing light.Due to a darkening under the crowns (microleakage), the health care professional had to cut off all of the restorations.

• Brand Name: VARIOLINK VENEER
• Type of Device: MATERIAL, TOOTH SHADE, RESIN
• Manufacturer (Section D): IVOCLAR VIVADENT AG; bendererstrasse 2; schaan, ls 9494 ; LS 9494
• Manufacturer (Section G): IVOCLAR VIVADENT AG; bendererstrasse 2; schaan, li 9494 ; LS 9494
• Manufacturer Contact: donna hartnett ; 175 pineview drive; amherst, NY 14228 ; 7166912260
• MDR Report Key: 6456204
• MDR Text Key: 71907280
• Report Number: 9612352-2017-00002
• Device Sequence Number: 1
• Product Code: EBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K901917
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 591425AN
• Device Lot Number: U33189
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other