BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMARK DENTAL IMPLANT SYSTEM

    MDR report key: 3020612 · Received March 21, 2013

    Report

    Report Number
    1287163-2013-00028
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    December 21, 2012
    Report Date
    March 18, 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 OF ENDOSSEOUS DENTAL IMPLANT. IMPLANT WAS PLACED ON (B)(6) 2012 (TYPE III BONE). BIOMECHANICAL OVERLOAD WAS INVOLVED IN THE EVENT. THE CLINICIAN REPORTS PREMATURE LOADING/PRESSURE FROM A PROVISION PROSTHESIS. THE IMPLANT WAS REMOVED ON (B)(6) 2013 DUE TO SWELLING, PAIN. MED HISTORY: NO SIGNIFICANT FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118350 MINIMARK DENTAL IMPLANT SYSTEM 3.25 X 10MM W 2MM CUFF MINIMARK IMPLANT DZE ACE SURGICAL SUPPLY CO., INC. 10321020 12020084

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention