BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXCEM ELITE

    MDR report key: 3050681 · Received April 10, 2013

    Report

    Report Number
    2024312-2013-00131
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 13, 2013
    Manufacturer
    KERR CORPORATION
    Product Code
    EMA
    PMA / PMN Number
    K073209
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 GRINDS THE CROWN TO FIT THE PATIENTS BITE; HOWEVER, THE DOCTOR HAD TO REMOVE THE PATIENT'S CROWN DUE TO THE IMPROPER FIT WHICH LEFT OPEN MARGINS. THE DOCTOR CUT OFF THE CROWN AND COMPLETED THE PATIENT RESTORATION BY RE-CEMENTING A NEW CROWN FOR THE PATIENT. TO DATE, THE PATIENT IS FINE. THE PRODUCT INVOLVED IN THE ALLEGED INCIDENT WAS NOT RETURNED. THE LOT NUMBER 4720555 HAS BEEN IDENTIFIED AS AN AFFECTED LOT WHICH IS PART OF AN ONGOING MAXCEM ELITE RECALL.

    Description of Event or Problem · 1

    A DOCTOR'S OFFICE ALLEGED THAT THE CEMENT WAS SETTING UP TOO QUICKLY FOR ONE PATIENT CAUSING THE DOCTOR RE-DO THE RESTORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152225 MAXCEM ELITE CEMENT, DENTAL EMA KERR CORPORATION 4720555

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R