BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M ESPE STAINLESS STEEL PRIMARY MOLAR CROWN

    MDR report key: 6786844 · Received August 10, 2017

    Report

    Report Number
    3005174370-2017-00044
    Event Type
    Injury
    Date Received
    August 10, 2017
    Report Date
    August 10, 2017
    Manufacturer
    3M ESPE DENTAL PRODUCTS
    Product Code
    ELZ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON 3M FOLLOW-UP WITH THE PATIENT'S PEDIATRIC DENTIST WHO PLACED THE STAINLESS STEEL CROWN, A PERFORATION OF A STAINLESS STEEL CROWN IS NOT UNUSUAL, ESPECIALLY AFTER ALMOST THREE YEARS, AND COULD BE CAUSED BY THE MASTICATORY FUNCTION OF THE CHILD OR BRUXISM. HOWEVER, IT SHOULD BE NOTED THAT 3M HAS NOT RECEIVED ANY SIMILAR COMPLAINTS OF THIS NATURE IN THE PAST. THIS EVENT INVOLVED TWO 3M PRODUCTS; THEREFORE, TWO MANUFACTURER REPORTS ARE BEING SUBMITTED. THIS REPORT REPRESENTS THE FIRST PRODUCT. MANUFACTURER REPORT 3005174370-2017-00045 REPRESENTS THE SECOND PRODUCT.

    Description of Event or Problem · 1

    ON (B)(6) 2017, 3M WAS NOTIFIED THAT AN (B)(6) MALE PATIENT REQUIRED A TOOTH EXTRACTION DUE TO TOOTH DECAY WHICH WAS NOTED AFTER A 3M STAINLESS STEEL CROWN FELL OFF HIS TOOTH. THE STAINLESS STEEL CROWN WAS REPORTED TO HAVE A HOLE IN THE CENTER SURFACE. THE CROWN WAS ORIGINALLY PLACED IN (B)(6) 2014 USING 3M ESPE RELYX LUTING PLUS CEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564091 3M ESPE STAINLESS STEEL PRIMARY MOLAR CROWN CROWN, PREFORMED ELZ 3M ESPE DENTAL PRODUCTS

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention