BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELYX ULTIMATE ADHESIVE RESIN CEMENT

    MDR report key: 4990601 · Received August 7, 2015

    Report

    Report Number
    9611385-2015-00011
    Event Type
    Injury
    Date Received
    August 7, 2015
    Date of Event
    June 18, 2015
    Report Date
    July 10, 2015
    Manufacturer
    3M DEUTSCHLAND
    Product Code
    EMA
    PMA / PMN Number
    K110508
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT DESCRIBES THE SECOND DEVICE. MANUFACTURER REPORT NUMBERS 3005174370-2015-00049 AND 9611385-2015-00011, DESCRIBE THE FIRST AND THIRD DEVICE, RESPECTFULLY.

    Additional Manufacturer Narrative · 1

    SINCE THIS EVENT INVOLVED THREE MEDICAL DEVICES, THREE MANUFACTURER REPORTS ARE BEING SUBMITTED. THIS REPORT DESCRIBES THE THIRD DEVICE. MANUFACTURER REPORT NUMBERS 3005174370-2015-00049 AND 9611385-2015-00010, DESCRIBE THE FIRST AND SECOND DEVICE, RESPECTFULLY.

    Description of Event or Problem · 1

    A DENTIST REPORTED THAT ONE OF HER PATIENTS REQUIRED EXTRACTION OF TOOTH #29. THIS PATIENT HAD A CROWN PLACED ON (B)(6) 2014, MADE FROM 3M ESPE LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC, WHICH WAS SEATED WITH 3M ESPE RELYX ULTIMATE CEMENT AND 3M ESPE SCOTCHBOND UNIVERSAL ADHESIVE. ON (B)(6) 2015, IT WAS NOTED THAT LEAKAGE HAD OCCURRED RESULTING IN SECONDARY CARIES; BECAUSE THE TOOTH HAD RECEIVED ENDODONTIC TREATMENT IN THE PAST (DETAILS NOT PROVIDED TO 3M ESPE), THE CARIES PROGRESSED UNDETECTED TO A POINT WHERE EXTRACTION WAS THE ONLY TREATMENT OPTION. THE PATIENT WILL RECEIVE AN IMPLANT.

    Description of Event or Problem · 1

    A DENTIST REPORTED THAT ONE OF HER PATIENTS REQUIRED EXTRACTION OF TOOTH #29. THIS PATIENT HAD A CROWN PLACED ON (B)(6) 2014, MADE FROM 3M ESPE LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D, WHICH WAS SEATED WITH 3M ESPE SCOTCHBOND UNIVERSAL ADHESIVE AND 3M ESPE RELYX ULTIMATE CEMENT. ON (B)(6) 2015, IT WAS NOTED THAT LEAKAGE HAD OCCURRED RESULTING IN SECONDARY CARIES; BECAUSE THE TOOTH HAD REC'D ENDODONTIC TREATMENT IN THE PAST (DETAILS NOT PROVIDED TO 3M ESPE), THE CARIES PROGRESSED UNDETECTED TO A POINT WHERE EXTRACTION WAS THE ONLY TREATMENT OPTION. THE PATIENT WILL RECEIVE AN IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521240 RELYX ULTIMATE ADHESIVE RESIN CEMENT DENTAL CEMENT EMA 3M DEUTSCHLAND

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other