MAUDE Adverse Event Report: KNIGHT LAB BRUXZIR CROWN PRIZMATEK ZIRCONIA; DENTAL CROWN

Device Problems Break (1069); Patient-Device Incompatibility (2682); Positioning Problem (3009)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Event Description

(b)(6).Dates of visit: (b)(6) 2013: made an appointment for a porcelain crown replacement for #3 upper right that had broken.On (b)(6) 2013: emergency appointment with dr (b)(6) for a porcelain crown.Temporary crown was put on tooth #3 right upper side.On (b)(6) 2013: office appointment for new porcelain crown.Crown was put in.(i was not told that the crown was "prizmatek zirconia").There was problems putting the crown in my mouth.Water was all over my mouth.Water was all over my face and my clothes were wet.Dr (b)(6) kept drilling on the tooth going down into the gums to fit the crown.On (b)(6) 2013: called "(b)(6)" and spoke with (b)(6) and then was transferred to the owner (b)(6) about the crown her company had made for dr (b)(6) pt (b)(6).(b)(6) took all the info down about how my body was reacting to the material of the crown.(b)(6) then stated; that my crown was not porcelain and that i was having a reaction to the "bruxzir crown" made of "zirconia" and to see a doctor and have it immediately removed.Dr (b)(6) and his dental assistant personally assured (b)(6) that a porcelain crown was ordered.On (b)(6) 2013: office appointment for new porcelain crown.Dr.(b)(6) told me that it was a porcelain crown.I was overcharged; the crown made was not charged at the rate of "customary and reasonable".

Event Description

F/u report received on (b)(6) 2014: the attached is a letter about a (b)(6) dentist dr alfred (b)(6), who fraudulently did services on (b)(6), his pt without her knowledge or her permission.Pt went to dr (b)(6) for a "porcelain crown".Dr (b)(6) ordered a prizmatek zirconia crown and would not remove this crown resulting in the pt to have the crown removed and a porcelain crown put on with the total expense fallen on another dentist.Pt was ordered to leave dr (b)(6) office and accept the prizmatek zirconia crown.Pt is an "open heart" pt with a medical history of medical complications that dr (b)(6) was aware of; "medical history" on file.Pt had an open dialogue with dr (b)(6) of what material (porcelain) was to be used for #3 crown.Dr (b)(6) billed pt's insurance company for a porcelain crown that was not done.Dr (b)(6) billed insurance company for erroneous charges and amount that is not "usual and customary.".

• Brand Name: BRUXZIR CROWN PRIZMATEK ZIRCONIA
• Type of Device: DENTAL CROWN
• Manufacturer (Section D): KNIGHT LAB; 3659 amber road; oldsmar FL 34677
• MDR Report Key: 3607594
• MDR Text Key: 4175247
• Report Number: MW5034167
• Device Sequence Number: 1
• Product Code: EBG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 01/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Patient Sequence Number: 1
• Patient Outcome(s): Other