FDA Adverse Event Injury Summary report: N

DENTAL CROWN

MDR report key: 2916405 · Received January 9, 2013

Report

Report Number
MW5028587
Event Type
Injury
Date Received
January 9, 2013
Date of Event
November 29, 2007
Report Date
December 14, 2012
Manufacturer
GLIDEWELL LABORATORIES
Product Code
ELZ
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
PA, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

(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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
12857 DENTAL CROWN ELZ GLIDEWELL LABORATORIES

Patients

Seq Age Sex Outcome Treatment
1 41 YR Disability