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 2013-01-09 for DENTAL CROWN manufactured by Glidewell Laboratories.

Event Text Entries

[3304444] (b)(6) 2007, this was my initial visit with this dentist, as i was dissatisfied with previous dentists. I was not having any pain or problems at the time. I came there with four missing lower teeth, wanting to find out what could be done about it and i needed a teeth cleaning. The dentist looked at a biopsy report of the removed teeth, panoramic view x-ray, and my materials reactivity test (page 11 of 35) i brought with me. I had a photo taken of me. I had a complete set of x-rays taken (page 13 of 35) and an oral exam. I was told i had root canal teeth removed and it was good. Three out of the four lower teeth that were removed had crowns made of porcelain-fused to metal. There also was this same type of crown put on tooth #14 which had been on there since around 1994-1995. I was told that i needed to replace the crown because it had metal in it (looked like a natural tooth). The dentist did not want any metal in my mouth. I was told an all nonmetal one would be put in. That was because i left the dentist; look at a hair analysis (page 12 of 35) that was done earlier in the year showing high levels of toxic metal in my system. Dentist #(b)(6). I asked about the crown and i was told it had metal in it. I asked about the periodic pain. I was told it could be my bite is off, as most dentists do not think about checking the bite. My bite was adjusted here. To this day, i have been left with periodic pain in the area of tooth #14 and #15. I provided a billing statement to show what was done.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5028587
MDR Report Key2916405
Date Received2013-01-09
Date of Report2012-12-14
Date of Event2007-11-29
Date Added to Maude2013-01-17
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 FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Generic NameDENTAL CROWN
Product CodeELZ
Date Received2013-01-09
Device AvailabilityY
Device Sequence No1
Device Event Key0
ManufacturerGLIDEWELL LABORATORIES
Manufacturer Address4141 MCCARTHUR BLD NEWPORT BEACH CA US


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2013-01-09

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