BRUXZIR 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 2016-09-19 for BRUXZIR DENTAL CROWN manufactured by Bruxzir Usa (http://www.bruxzir.com).

Event Text Entries

[55464863] On (b)(6) 2015 dr. (b)(6) placed a bruxzir (zirconium oxide) dental crown on tooth #31. Began experiencing symptoms of tingling around underside of upper and lower lips, swollen tongue, metallic taste, excess salivation, impaired ability to swallow saliva, all worsening over the next 4 weeks after placement. Addressed with dr (b)(6) as i had also started a new diuretic, chlorthalidone 25 mg daily. After several weeks of symptoms, dr (b)(6) switched me to lisinopril/hctz 10-12. 5 mg thinking symptoms medication related. After several weeks and no relief, i went off all medication for 15 days. Symptoms did not lessen. Restarted lisinopril/hctz. No changes. Readdressed with dr (b)(6) who switched my medication a 3rd time to amlodipine 5 mg daily. After several weeks on new therapy with no lessening of symptoms, i contacted my dentist dr (b)(6) about (b)(6) 2015 crown. I never had trouble with previous 6 so i asked if used something new: yes, the bruxzir crown, made of a white metal, zirconium oxide (not covered in porcelain as my past 6 crowns were). He asked if i could be tested for allergy. I could not locate an allergist who could test for zirconium oxide. I asked again if he would take it off and replace with porcelain covered npm crown. He removed and replaced my crown (b)(6) 2016. By suppertime my tongue was back to normal. I no longer had any lisping from swollen tongue, my swallowing of saliva was normal. After 5 weeks the metallic taste was finally gone. Excess salivation is lessening, but still evident as of today, (b)(6) 2016. In (b)(6), allergist dr. (b)(6) skin tested me for zirconium oxide allergy. Though it was negative, he said test not flawless and tongue swelling is evidence i should avoid zirconium in the future.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5064961
MDR Report Key5969899
Date Received2016-09-19
Date of Report2016-10-09
Date of Event2015-06-16
Date Added to Maude2016-09-22
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameBRUXZIR DENTAL CROWN
Generic NameBRUXZIR DENTAL CROWN
Product CodeNSP
Date Received2016-09-19
Device Availability*
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerBRUXZIR USA (HTTP://WWW.BRUXZIR.COM)


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2016-09-19

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