IPS EMPRESS DIRECT COMPOSITE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-20 for IPS EMPRESS DIRECT COMPOSITE manufactured by Ivoclar Vivadent Ag.

Event Text Entries

[139555143] Required removal of flawed product and replacement with new, which was charged as a new procedure by my dentist. Less than 3 yrs ago, my dentist applied / installed several "fillings" to the front surfaces of some of my teeth using ips empress direct composite dental filling material. I had never had any procedure like this done before, so i didn't know what to expect. I had previously had composite fillings that replaced amalgam fillings in molars, and both the amalgam fillings and the replacement composite fillings have lasted many years, and they are all still intact as far as i recall. In (b)(6) 2018, i noticed a very odd texture on the front surface of one of the treated teeth. It was just before the (b)(6) holidays, but i was able to be seen by my dentist. He informed me that the filling material had come off. I said i didn't recall eating / drinking anything that would cause this, and he confirmed that this just sometimes happens and i should not feel responsible. I was able to get an appt with my dentist on (b)(6) 2019. I subsequently called my dentist's office for the name of the composite used because after replacement i decided i wanted to research the longevity of the filling material. They told me it was ips empress direct composite material. I read online info about this product and could not find any reference to expected durability / longevity, but i believe it is substandard for an anterior filling to last less than 3 years. I do not routinely eat hard, crunchy foods nor do i chew on bones, so i do not believe i did anything to cause this problem.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5085062
• MDR Report Key: 8439811
• Date Received: 2019-03-20
• Date of Report: 2019-03-12
• Date of Event: 2018-12-17
• Date Added to Maude: 2019-03-21
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 0

• Brand Name: IPS EMPRESS DIRECT COMPOSITE
• Generic Name: POWDER, PORCELAIN
• Product Code: EIH
• Date Received: 2019-03-20
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: IVOCLAR VIVADENT AG

Device Sequence Number: 1

• Brand Name: IPS EMPRESS DIRECT COMPOSITE
• Generic Name: POWDER, PORCELAIN
• Product Code: EIH
• Date Received: 2019-03-20
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: IVOCLAR VIVODENT AG

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	2019-03-20