BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4X13MM MDI MAX WITH O-BALL HEAD AND COLLAR

    MDR report key: 3214046 · Received July 3, 2013

    Report

    Report Number
    3005174370-2013-00018
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    May 14, 2013
    Report Date
    June 4, 2013
    Manufacturer
    3M ESPE DENTAL PRODUCTS
    Product Code
    DZE
    PMA / PMN Number
    K031106
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, 3M ESPE WAS INFORMED OF TWO MDI IMPLANTS THAT HAD BEEN LOST INTO THE PATIENT'S SINUS CAVITY. THE IMPLANTS WERE PLACED ON (B)(6) 2013, AND AT A 4 MONTH CHECK-UP, THEY WERE MISSING. X-RAYS DETERMINED THEM TO HAVE BEEN DISPLACED INTO THE SINUS CAVITY (ONE IN THE RIGHT AND ONE IN THE LEFT). THE PATIENT IS BEING REFERRED TO AN ORAL SURGEON FOR SURGICAL REMOVAL CONSULTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305646 2.4X13MM MDI MAX WITH O-BALL HEAD AND COLLAR DENTAL IMPLANT DZE 3M ESPE DENTAL PRODUCTS MOB-13

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention