MAUDE Adverse Event Report: CROWN ON TOOTH #19; CROWN, PREFORMED

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Diarrhea (1811); Pain (1994); Vomiting (2144); Anxiety (2328); Depression (2361); Weight Changes (2607); Convulsion/Seizure (4406); Suicidal Ideation (4429); Metal Related Pathology (4530)

Event Date 01/01/2018

Event Type  Injury  

Event Description

Unclear on dates.Brought chronic disability chart to dentist, who did dental work.He (the owner) changed me to another dentist in the middle of my care.(he has just been reported for the 3rd time) horrible pain from a crown on wrong by ineligible person, he would not fix it and almost all side effects of elemental and inorganic mercury poisoning(mercury poisoning 5 removals).No protocol used for me or service dog in removing mercury.Pcp(primary care physician) gave up and other docs.I refused hospitalization as i had researched enough to know they couldn't save their own researchers.Functional doc was found, and strict protocol of detoxing was used, and pcp was pleased.Rage, other frontal lobe issues, tbi(traumatic brain injury) worsened, never before had severe anxiety/depression/suicidal thoughts, couldn't eat from pain, throwing up and diarrhea over the bed, floor, finally wore diapers.I refused any testing as i had to convince my brain to live.All testing was done after i felt it was safe.Cerescan (spect scan) done.24 hour special urine test and blood test.Utmb and pcp said it would take a long time to leave tissues.Still have pain in mouth.Results showed damage was healing, thankfully lost 60 pounds.Blood pressure was 199/130 and above.Seizures came back, strokes, i wrote, but messages can't be retrieved from fb(facebook) messenger.I reported him, as docs after service dog died.She was so sick.Utmb notes all mistakes, and trauma with pain.Ada(american dental association) rejected detailed report, even with my team of docs waiting to discuss.Pcp still wants something done.Dentist told dental assoc he didn't do it.So they wanted me to report another.Ignored by osha(occupational safety and health administration) and epa(environmental protection agency).Very obvious as others in city are suffering.I have a complete notebook with all involved, dates, tests, etc.So does ada, although they do not listen.I'm sorry, i can't write, but i have all reports, a huge binder, but this will cause a flare and depression/anxiety tonight.I am under treatment now with acupuncture and it is only a 8 on the pain scale when talking in the front "mental" nerve area.The dystonia pulls the skull bones out, so they must be pushed back into place rsd is seen on my tongue - very red.No throwing up, blood pressure doing much better.Trauma is an issue and others are being hurt.I want him to stop hurting others, to take responsibility and to stop being protected after so many events he has been reported with.I'm sorry, i wish i could help more, but i will have to do it in person or with my doctor.Dr.(b)(6).Reported and suspended license twice and then approx in 2018.Not documented, but all records show he did it and i know which tooth.Pcp(primary care physician) oversees all of the teams testing and medicine.I have weaned from a lot, before the incident, and now am back to weaning.Reference reports: mw5115300, mw5115301, mw5115302, mw5115303, mw5115304.

• Brand Name: CROWN ON TOOTH #19
• Type of Device: CROWN, PREFORMED
• MDR Report Key: 16459339
• MDR Text Key: 310445301
• Report Number: MW5115299
• Device Sequence Number: 1
• Product Code: ELZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: 5HTP; CPAP - NOT ABLE TO USE AS VAPOR BURNED THE MEMBRANE IN SINUS AREA; DIAZEPAM; KEPPRA; MAGNESIUM/ZINC/VIT C ; MIRAPEX; MORPHINE/BACLOFEN; MULTIVITAMIN; NAD(NICOTINAMIDE ADENINE DINUCLEOTIDE); NERVE PAIN MED; NRF1; NRF2; PAIN PUMP
• Patient Outcome(s): Life Threatening; Disability; Required Intervention; Other
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White