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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: E-MAX CROWN (DENTAL LITHIUM DISILICATE); POWDER PORCELAIN

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E-MAX CROWN (DENTAL LITHIUM DISILICATE); POWDER PORCELAIN Back to Search Results
Medical Device Problem Code Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes Headache (1880); Inflammation (1932); Memory Loss/Impairment (1958); Pain (1994); Thyroid Problems (2102); Tingling (2171); Cramp(s) (2193); Discomfort (2330); Sweating (2444); Palpitations (2467); Shaking/Tremors (2515); Sleep Dysfunction (2517); Confusion/ Disorientation (2553); Alteration In Body Temperature (2682)
Date of Event 12/12/2018
Type of Reportable Event Serious Injury
Event or Problem Description
Reporter alleges she had e-max crowns implanted by her dentist on (b)(6) 2018.She started feeling discomfort due to crown not fitting properly.Dentist advised it needed adjustment but she ended up in the er on (b)(6) 2018 due to pain from kidney stones.After discharge from the hospital she never got improvement and experienced racing heartbeat, chills, sweating, headaches, pain, cramps, insomnia and inflammation.These symptoms progressively got worse and she went back to er on (b)(6) 2019.She was discharged home with medications to address her symptoms and a follow up appointment with her primary physician.The sweating got worse and she constantly changed her night gowns at night.On (b)(6) 2019, she saw her physician with more symptoms including confusion, memory loss, twitching, shaking, metallic taste in mouth, thyroid issues and the worst symptom was a buzzing feeling going through toes and fingers that made her walk in circles in her living room to help her cope with the discomfort.On (b)(6) 2019 she had her dentist explant the crowns and went for traditional porcelain replacement and within 5 days all her symptoms wer improving.She wants the fda to be aware of the side effects from thee-max crowns and to warn other patients who have lithium disilicate to be aware of the dangers of these crowns.
 
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Brand Name
E-MAX CROWN (DENTAL LITHIUM DISILICATE)
Common Device Name
POWDER PORCELAIN
MDR Report Key9426867
Report NumberMW5091509
Device Sequence Number3806791
Product Code EIH
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2019
Reporter Type Voluntary
Type of Report Initial
Report Date (Section B) 12/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device No Information
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date12/05/2019
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age60 YR
Patient Weight64
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