MAUDE Adverse Event Report: IVOCLAR VIVADENT, INC. VIRTUAL XD; MATERIAL, IMPRESSION

Catalog Number 616448

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 05/13/2016

Event Type  No Answer Provided  

Event Description

Doctor called that the heavy body xd fast set is not setting at the same rate as the wash material that is being used in conjunction.Doctor claims it caused a chipped porcelain on a patient upon removal.

• Brand Name: VIRTUAL XD
• Type of Device: MATERIAL, IMPRESSION
• Manufacturer (Section D): IVOCLAR VIVADENT, INC.; 175 pineview drive; amherst NY 14228
• Manufacturer (Section G): IVOCLAR VIVADENT, INC.; 175 pineview drive; amherst NY 14228
• Manufacturer Contact: donna hartnett ; 175 pineview dr; amherst, NY 14228 ; 7166912260
• MDR Report Key: 5730164
• MDR Text Key: 47552618
• Report Number: 1316092-2016-00003
• Device Sequence Number: 1
• Product Code: ELW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083739
• 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: 06/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 616448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other