BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMARK DENTAL IMPLANT SYSTEM

    MDR report key: 3181572 · Received June 17, 2013

    Report

    Report Number
    1287163-2013-00058
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    May 21, 2013
    Report Date
    June 13, 2013
    Manufacturer
    ACE SURGICAL SUPPLY CO.
    Product Code
    DZE
    PMA / PMN Number
    K092594
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. IMPLANT WAS PLACED ON (B)(6) 2013 (TYPE III BONE). THE CLINICIAN REPORTS THAT BONE ATROPHY AROUND THE IMPLANT WAS THE REASON FOR THE FAILURE. BONE ATROPHY WAS INVOLVED IN THE EVENT. THE IMPLANT WAS REMOVED ON (B)(6) 2013. MED HISTORY: NO SIGNIFICANT FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274023 MINIMARK DENTAL IMPLANT SYSTEM 2.9X13 W 2MM CUFF MINIMARK IMPLANT DZE ACE SURGICAL SUPPLY CO. 10291320 12010076

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention