MAUDE Adverse Event Report: 3M ESPE DENTAL PRODUCTS FILTEK SUPREME ULTRA; MATERIAL, TOOTH SHADE, RESIN

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Autoimmune Disorder (1732); Chest Pain (1776); Dyspnea (1816); Fatigue (1849); Pain (1994)

Event Date 05/03/2007

Event Type  Injury  

Event Description

I am writing to complain about plastic/composite dental filling materials in general.They are being adulterated with an adhesive that is possibly a glass ionomer cement in order to make them easier to place and in order to deliberately cause patients chronic pain so that the patients return to the dental practice and can then be up-sold on endodontic therapy and/or dental implants.Composite filling materials are supposed to have an adhesive placed underneath the filling material instead of the adhesive being mixed with the composite filling material itself.I have seen these adulterated composite filling materials referred to as "resin composite" on two different treatment plans that i received from two different dental practices.The pain that is caused by these adulterated composite fillings is caused by polymerization stress that pulls on the walls of the tooth's cavity.This extreme polymerization stress from adulterated composite fillings also causes 'secondary raynaud's phenomenon' and scleroderma.I found a study (pmcid: pmc7044382) published on 17 jan 2020 in which a patient has preexisting composite fillings and scleroderma.An attempt is never made in this study to connect the preexisting composite fillings and the scleroderma.Here is a quote from the study: "bitewings showed eight existing composite restorations and four grossly carious teeth." secondary raynaud's phenomenon is known to be caused by an injury ¿ and in this case the injury is the extremely high polymerization stress of adulterated composite fillings.This is a more detailed list of my symptoms after the adulterated composite fillings were placed: secondary raynaud's phenomenon of some of my fingertips, scleroderma of the sides of some of my fingers, chest pain and tiredness upon physical exertion possibly due to scleroderma of my heart, and shortness of breath possibly due to scleroderma of my lungs.I looked at previous complaints of composite fillings on the fda website and noticed that some people complain of shortness of breath, which i noticed was being attributed to an allergic reaction, with a proposed solution being allergy testing.Allergies are caused by proteins that the body cannot break down, so this is not likely a case of an allergic reaction since composite fillings do not likely contain protein.A more likely explanation for the symptom of shortness of breath is scleroderma of the heart that is caused by the extreme polymerization stress of adulterated composite fillings.Another problem with adulterated composite fillings is that they do not cure properly, which makes them soft and flexible, which also causes even more pain when chewing since the adulterated composite filling pushes on the dentin.I was able to relieve most of the above-mentioned symptoms by further curing my adulterated composite fillings with a soldering iron and then drilling holes into my adulterated composite fillings in order to relieve the polymerization stress that was compressing the nerves and blood vessels in my teeth.I still have these adulterated composite fillings in my teeth if any evidence is needed but i do not know if it is possible to do fourier-transform infrared spectroscopy (ftir) on little bits of dust that would have to be drilled out of my teeth and saved.I called the dental practice in late 2011 or early 2012 and was told that the filling material was filtek supreme ultra, but any composite filling material can be adulterated so this is not really important.I have since visited another dental practice and mentioned how the filling material was not placed according to the manufacturer's directions in that an adhesive was not placed onto my teeth as a separate step and was told "yeah, right!".Here is the title of the study from above: "dental management of scleroderma patients using pentoxifylline plus vitamin e with and without therabite to reduce trismus: two case reports and brief review of literature".Fda safety report id# (b)(4).

• Brand Name: FILTEK SUPREME ULTRA
• Type of Device: MATERIAL, TOOTH SHADE, RESIN
• Manufacturer (Section D): 3M ESPE DENTAL PRODUCTS
• MDR Report Key: 12665113
• MDR Text Key: 277870242
• Report Number: MW5104773
• Device Sequence Number: 1
• Product Code: EBF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention; Disability