ZENITH

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-06-29 for ZENITH manufactured by Foremost Dental Mfg., Inc..

Event Text Entries

[15029068] Rptr writes, "i'm a seventy-two yr old woman and have researched dental fillings and anesthesias. They are responsible for my allergenic rheumatoid arthritis. It involved the side effects that includes painful distorted feet, swollen ankles and hands, fatty tumors, nodules, painful blood-shot eyes, collapsed arches, loss of hair, etc i have experienced. I have found dental products were changed to 25 yrs ago in secrecy, why the secrecy? I remember when silicate (a porcelain synthetic), amalgum (silver) tin fillings with mercury and anesthesia without epinephrine were used without any side effects. The anesthesia numbed the mouth and jaw longer and preservatives were not used. When epinephrine (adrenalin) a vasoconstrictor is added, it tightens both veins and tendons causing painful destortions and poor circulation permanetnly. Methylparaben causes swollen ankles the size of golf balls making it impossible to walk. (carbocaine). Because of the absence of silicate, i telephoned dental mfrs in the us, including one who formally made it. I was informed economically it was not feasible to produce silicate, no one uses it. Plastic composite is composed of oils and used extensively for fillings, dentures, etc and cheaper to mfr then silicate. Dentists, have tried to order silicate, but were told it is obsolete. At my insistance of a patch test, an allergist applied a piece of plastic composite on my arm. Since it was a first time experiment, no one knew what to expect. Five mins later, my arm felt cold and one hr later, started to ache until i removed the tape. It did not leave a mark! Ordinarily, allergy tests would show a dot or lump, but never any pain. Mos later, when a piece of plastic filling 1/8 of an inch long called durafill by kulzer became loose, i wrapped it on my arm. Forty mins later, the pain was unbearable. I pulled the band aid off to alleviate the pain. Meanwhile, with the filling out of my tooth the pain in my left foot disappeared. And then, after three and one half yrs, when the tooth was filled, i stopped limping and stopped going down the stairs like a toddler. It proves the fillings act like a splinter. Until its removed, it injures the nerve triggering symptoms resembling rheumatoid arthritis. Unfortunately, several days later the tooth was refilled with plastic composite filling zenith causing gum muscle spasm, irritation, sensitive elbows, arm and shoulder enlargements and more loss of hair etc. Then there is the new copper amalgum, it twists muscles into nodules the size of marbles in my feet. When the dentist replaced another new amalgum with the old tin mercury amalgum, the pain in my left foot subsided gradually. Never experienced anything like it! In ten min!. My dentist said i cannot get silicate on the market again. I need your help to publicize the allergys to plastic fillings. I know of others having dental problems too. Statistics say, there are 11,000 children with rheumatoid arthritis.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW4002303
MDR Report Key180071
Date Received1998-06-29
Date Added to Maude1998-08-04
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameZENITH
Generic NamePLASTIC COMPOSITE FILLING
Product CodeEBD
Date Received1998-06-29
Model NumberNI
Catalog NumberNI
Lot NumberNI
ID NumberNI
Device AvailabilityN
Implant FlagN
Date RemovedI
Device Sequence No1
Device Event Key175108
ManufacturerFOREMOST DENTAL MFG., INC.
Manufacturer Address242 SOUTH DEAN ST. ENGLEWOOD NJ 07631 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1998-06-29

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