BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMARK DENTAL IMPLATN SYSTEM

    MDR report key: 3576904 · Received January 6, 2014

    Report

    Report Number
    1287163-2013-00121
    Event Type
    Injury
    Date Received
    January 6, 2014
    Date of Event
    December 11, 2013
    Report Date
    December 31, 2013
    Manufacturer
    ACE SURGICAL SUPPLY CO., INC.
    Product Code
    DZE
    PMA / PMN Number
    K092594
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IMPLANT FAILURE. INITIAL STABILIZATION OBTAINED AND HAS BEEN INTEGRATED FOR 10 MONTHS BEFORE LOADED AND IS REJECTED 3 WEEKS AFTER LOAD. SITE: NUMBER 6. IMPLANT PLACEMENT: (B)(6) 2013. PROSTH. RESTORATION: (B)(6) 2013. DATE OF IMPLANT REMOVAL: (B)(6) 2013. BONE QUALITY TYPE: III. AT TIME OF IMPLANT FAILURE THERE WAS MOBILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8115 MINIMARK DENTAL IMPLATN SYSTEM MINIMARK, DENTAL IMPLANT DZE ACE SURGICAL SUPPLY CO., INC. 10-23-1020 12020075

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention