BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELYX (TM( LUTING PLUS CEMENT

    MDR report key: 4530366 · Received February 18, 2015

    Report

    Report Number
    3005174370-2015-00013
    Event Type
    Injury
    Date Received
    February 18, 2015
    Date of Event
    April 16, 2013
    Report Date
    January 20, 2015
    Manufacturer
    3M ESPE DENTAL PRODUCTS
    Product Code
    EMA
    PMA / PMN Number
    K111185
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ENGINEERING INVESTIGATION WAS LIMITED BY LACK OF RETURNED PRODUCT AND A LOT NUMBER INFO; DENTAL OFFICE DID NOT HAVE A PRODUCT TO RETURN OR A LOT NUMBER FOR THE PRODUCT USED SINCE THE PROCEDURE WAS DONE IN (B)(6) 2013. THE COMPLAINT HISTORY WAS SEARCHED FROM 2009 THROUGH 2014; NO COMPLAINTS HAVE BEEN REPORTED TO 3M ESPE FOR LOSS OF TASTE ASSOCIATED WITH EITHER RELYX LUTING PLUS CEMENT OR FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE. BOTH OF THESE PRODUCTS HAVE BEEN EVALUATED FOR BIOCOMPATIBILITY AND FOUND TO BE SAFE FOR THEIR INTENDED USE. THERE ARE TWO SUSPECT MEDICAL DEVICES INVOLVED IN THIS EVENT DESCRIBES THE FIRST SUSPECT MEDICAL DEVICE. MFR REPORT #030051742370-2015-00014 PROVIDES INFO ON THE SECOND SUSPECT DEVICE INVOLVED IN THIS EVENT.

    Description of Event or Problem · 1

    A PT BEGAN TO TASTED METAL AND THEN EVENTUALLY LOST ALL SENSE OF TASTE A COUPLE DAYS AFTER A CROWN CEMENTATION PROCEDURE DONE ON (B)(6) 2013. THE CEMENT USED TO SEAT THE CROWN WAS 03 (TM) ESPE (TM) RELYX (TM) LUTING PLUS CEMENT. THE CROWN USED IN THE PT'S MOUTH WAS A PORCELAIN FUSED TO A HIGH NOBLE METAL CROWN (NOT A 3M ESPE PRODUCT). A 3M (TM) ESPE (TM) FILTEK (TM) SUPREME ULTRA UNIVERSAL RESTORATIVE WAS ALSO MENTIONED BY THE DENTAL OFFICE AS A POTENTIAL CONTRIBUTOR TO THE PT'S SYMPTOMS; IT IS NOT CLEAR HOW THIS PRODUCT IS CONNECTED WITH THE SEATING OF THE CROWN. THE DENTAL OFFICE STATED THEY THINK THE SYMPTOMS ARE MORE ASSOCIATED WITH THE CROWN THAN EITHER OF THE 3M ESPE PRODUCTS; HOWEVER, THE PT IS CURRENTLY PURSUING ALLERGY TESTING. THE 3M ESPE HAS MADE SEVERAL ATTEMPTS TO FOLLOW-UP WITH THE DENTAL OFFICE FOR CURRENT PT STATUS AND RESULTS OF ANY ALLERGY TESTING PERFORMED; THE DENTAL OFFICE HAS NOT HEARD BAC AT THIS TIME FROM THE PT OR THE DERMATOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115262 RELYX (TM( LUTING PLUS CEMENT DENTAL CEMENT EMA 3M ESPE DENTAL PRODUCTS

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Disability