ZIRCONIA DENTAL CROWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-14 for ZIRCONIA DENTAL CROWN manufactured by Unk.

Event Text Entries

[145477145] I became sick 2 days after a zirconium crown was inserted into my mouth. This was the 2nd zirconium crown, the first one having been placed less than a year before this. The symptoms affected my brain equilibrium to a high degree. I had mild nausea when i changed the position of my head (like if i turned when sleeping), dizziness upon standing, and a sense of imbalance. I monitored new symptoms every day for about 6 weeks. Milder symptoms were facial flushing, strange acidic taste in the mouth, tiredness and sleeping throughout the day, oversleeping in the morning and waking up with no energy. There was no feeling of being well rested anymore after a night's sleep and no surges of energy throughout the day. These symptoms were life-changing for me as i am usually in good health without underlying med conditions. I take no meds and just a few vitamins a day to day healthy. There were no changes in my diet. I immediately suspected something with the 2nd crown but as there was no local inflammation and the crowns felt great - i did not want to jump to conclusions and have them removed quickly. I kept waiting for the symptoms to go away but they didn't. When i looked on the internet i started to read about some people who had removed their zirconium crowns for various reasons. I also read that it is a radioactive substance and think this was the source of my problems. It seems i had radioactive toxicity when the 2nd crown was inserted. It is very concerning to me that this could happen to a person because it would be hard to figure out what is causing these symptoms. It is therefore my duty to report my problem to you in hopes that you are keeping data on this product that can be made available to dental providers. My dentist just insisted that he's been using for 10 years without pt complaint. I'm very happy to say that i disregarded his claims and went on my own hunches and had the 2 crowns removed first week of may. Two days later, i got my health back and now have my normal energy level back as well. The nausea and dizziness are gone and my equilibrium is restored. It is hard for me to believe that i was that sick before. The difference in the way i feel is remarkable. I would like this incident to be put on the record as an adverse side effect to zirconia crowns. I would also like a caution to be provided to dentists if they are planning to use this material in children. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5086664
MDR Report Key8612968
Date Received2019-05-14
Date of Report2019-05-10
Date of Event2019-03-19
Date Added to Maude2019-05-15
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameZIRCONIA DENTAL CROWN
Generic NameRESTORATION, PORCELAIN
Product CodeNSP
Date Received2019-05-14
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2019-05-14

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