BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXCEM ELITE CLEAR

    MDR report key: 3111086 · Received May 14, 2013

    Report

    Report Number
    2024312-2013-00201
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 21, 2013
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K073209
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SPECIFICS WITH REGARD TO GENDER AND AGE WERE NOT PROVIDED BY THE DOCTOR. THE DOCTOR WAS ABLE TO FULLY SEAT THE CROWN FOR THE PATIENT, WITHOUT FURTHER INCIDENT. TO DATE, THE PATIENT IS DOING FINE. A VISUAL TEST AND GEL SET TIME TEST WAS PERFORMED ON BOTH THE RETURNED AND RETAINED PRODUCT. IT WAS CONFIRMED THAT THE PRODUCT DID NOT MEET POLYMERIZATION SPECIFICATIONS. THIS LOT # 4720553 HAS BEEN IDENTIFIED AS AN AFFECTED LOT WHICH IS PART OF AN ONGOING MAXCEM ELITE RECALL.

    Description of Event or Problem · 1

    A DOCTOR ALLEGED THAT THE MAXCEM ELITE CLEAR PRODUCT HAD SET UP TOO QUICKLY WHILE CEMENTING A CROWN ON THREE PATIENT. THIS IS THE SECOND OF THREE (3) REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212958 MAXCEM ELITE CLEAR CEMENT, DENTAL EMA KERR CORPORATION 4720553

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R