VARIOUS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-07-30 for VARIOUS manufactured by .

Event Text Entries

[15607867] As a practicing dentist for 38 years, i have used both amalgam and composite resin restorations on posterior teeth for as long as composite has been available because patients like composites due to their tooth color. It has been my experience that composites are far inferior to amalgams on posterior teeth. They are extremely technique sensitive and very few dentists can and do use them properly. Even when the utmost of care is taken in placing composities in posterior teeth their life span is considerably less than properly placed amalgam restorations. Composites are much more difficult to place than amalgams and take more time to place, hence are more expensive. Composites are impossible to place without incorporating air bubbles which weaken the already weak material. Composites wear rapidly whereas amalgam wears very slowly. Composites break easily whereas amalgam is difficult to break. It is almost impossible to secure tight contacts between teeth with composites whereas it is easy with amalgams. There are many things that can be done with amalgam that cannot be done with composites. I have never seen an adverse reaction to an amalgam placed in any of my patients. Recent reports of some hydrocarbon compound released from composite resins in the mouth is of concern. If the use of amalgam is somehow limited - "fda sets 2009 deadline to reclassify amalgam" june ada news-, the general public not be able to receive good inexpensive dental care. Dates of use: 1985 -- 2008. Diagnosis or reasons for use: dental caries.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5007852
MDR Report Key1084875
Date Received2008-07-30
Date of Report2008-07-30
Date of Event2008-07-30
Date Added to Maude2008-08-07
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationDENTIST
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameVARIOUS
Generic NameCOMPOSITE RESINS FOR DENTAL USE, NUMEROUS
Product CodeEBD
Date Received2008-07-30
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key1070620


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2008-07-30

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