MAUDE Adverse Event Report: G-PREMIO BOND DENTAL BONDING AGENT; AGENT, TOOTH BONDING, RESIN

Model Number	NO. 012696
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Gc america dental device used to bond to tooth structure does not have activating component to allow the bonding agent to cure to tooth or subsequent dental composite when exposed to dental curing light.Therefore each restorative procedure that utilized this defective product or bonding agent will have restoration failure.Gc america sells g-premio bond which has no capacity to cure with dental light.Several lot numbers from gc america are involved with this defective product.In addition gc america has additional composite restorative material which also does not cure or harden when exposed to the dental curing light.This composite material failure was reported to the manufacturer gc america in (b)(6) 2020 as formal compliant.Unfortunately this same material had defective qualities in 2018.The current situation with the defective bonding agent from gc america which was used on hundreds of our dental patients in our practice, has dramatically shortened the life expectancy of such restorations in each and every patient.These failures will require additional dental therapy and may cause significant expense and possible tooth loss.Also this catastrophic event has placed my professional reputation in jeopardy.We are only one office with three dentists, imagine the hundreds of other dental offices which may be unaware of this event.This single avoidable event has placed thousands of patients in high risk of significant dental expenditures to remedy this problem.(b)(6), dds.Fda safety report id# (b)(4).

• Brand Name: G-PREMIO BOND DENTAL BONDING AGENT
• Common Device Name: AGENT, TOOTH BONDING, RESIN
• MDR Report Key: 10927366
• Report Number: MW5098148
• Device Sequence Number: 2469947
• Product Code: KLE
• UDI-Device Identifier: D0470126961
• UDI-Public: D0470126961
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Dentist
• Type of Report: Initial
• Report Date (Section B): 11/25/2020
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: NO. 012696
• Device Catalogue Number: 012696
• Device Lot Number: 2001211
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/30/2020
• Was Device Evaluated by Manufacturer? (Y/N): No Information
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 50