BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMARK DENTAL IMPLANT SYSTEM

    MDR report key: 3020611 · Received March 21, 2013

    Report

    Report Number
    1287163-2013-00029
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 20, 2013
    Manufacturer
    ACE SURGICAL SUPPLY CO., INC.
    Product Code
    DZE
    PMA / PMN Number
    K092594
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    REMOVAL IF ENDOSSEOUS DENTAL IMPLANT. IMPLANT WAS PLACED ON (B)(6) 2012 IN SITE AREA #4. AN INFECTION WAS INVOLVED IN THE EVENT. THE IMPLANT WAS REMOVED ON (B)(6) 2013 DUE TO MOBILITY. MED HISTORY: JOINT REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118906 MINIMARK DENTAL IMPLANT SYSTEM 3.25 X 10 W 2MM CUFF MINIMARK IMPLANT DZE ACE SURGICAL SUPPLY CO., INC. 10321020 12020084

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention