BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXCEM ELITE

    MDR report key: 3050712 · Received April 10, 2013

    Report

    Report Number
    2024312-2013-00120
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    March 4, 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
    AZ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DOCTOR GROUND THE BRIDGE FOR TEETH NUMBERS SEVENTEEN (17) THROUGH TWENTY (20) FOR THE PATIENT'S COMFORT. ON (B)(6) 2013, THE PATIENT RETURNED DUE TO THE BITE; THE DOCTOR PROCEEDED TO GROUND THE BRIDGE DOWN MORE TO MAKE IT MORE COMFORTABLE FOR THE PATIENT. ON (B)(6) 2013, THE DOCTOR CUT OFF THE FOUR (4) UNIT BRIDGE, TOOK A NEW IMPRESSION AND PUT ON TEMPORARIES FOR THE PATIENT. A NEW FOUR (4) UNIT BRIDGE WILL BE RE-CEMENTED. TO DATE, THE PATIENT IS DOING FINE. THE PRODUCT WAS NOT RETURNED. THE LOT NUMBER 4704821 HAS BEEN IDENTIFIED AS AN AFFECTED LOT 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 BRIDGE TO NO FULLY SEAT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150226 MAXCEM ELITE CEMENT, DENTAL EMA KERR CORPORATION 4704281

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other| R