BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMOND CROWN

    MDR report key: 2003216 · Received February 21, 2011

    Report

    Report Number
    MW5019496
    Event Type
    Injury
    Date Received
    February 21, 2011
    Date of Event
    January 1, 2010
    Report Date
    February 21, 2011
    Manufacturer
    DRM RESEARCH LABORATORIES, INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED 19 DENTAL CROWNS MADE FROM A LIGHT-CURED COMPOSITE MATERIAL KNOWN AS "DIAMOND CROWN", MANUFACTURED BY DRM RESEARCH LABORATORIES, INC. THE "DIAMOND CROWN" CROWNS WERE PLACED ON PT'S NATURAL TEETH IN 2006. THE ONLY PRODUCT WHICH THIS MANUFACTURER HAS APPROVED BY THE FDA IS A METAL IMPLANT PRODUCT (B)(4). THE "DIAMOND CROWN" MATERIAL HAS FAILED CROWNS LEAKING AND PT NOW REQUIRES CROWNS BE REPLACED. MANUFACTURER IS MARKETING "DIAMOND CROWN" PRODUCT AS BEING SUITABLE FOR USE AS CROWN MATERIAL ON NATURAL TEETH, BUT THE ONLY PRODUCT FDA HAS APPROVED FROM THIS MANUFACTURER IS A METAL IMPLANT (B)(4). LAWSUIT HAS BEEN FILED AGAINST MANUFACTURER FOR DEFECTIVE PRODUCT. IN LAWSUIT, MANUFACTURER CLAIMS "DIAMOND CROWN" HAS BEEN APPROVED FOR USE ON NATURAL TEETH, CITING LETTER FROM FDA DATED (B)(6) 2004. HOWEVER, SAID LETTER RELATES ONLY TO METAL IMPLANT PRODUCT - (B)(4) -. DIAGNOSIS OR REASON FOR USE: STOP DECAY OF NATURAL TEETH - RESTORATION OF NATURAL TEETH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAMOND CROWN DIAMOND CROWN DZE DRM RESEARCH LABORATORIES, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Disability