BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMARK DENTAL IMPLANT SYSTEM

    MDR report key: 3152560 · Received June 5, 2013

    Report

    Report Number
    1287163-2013-00051
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    April 10, 2013
    Report Date
    June 4, 2013
    Manufacturer
    ACE SURGICAL SUPPLY CO.
    Product Code
    DZE
    PMA / PMN Number
    K092594
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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). PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. THE CLINICIAN STATES THAT 4 IMPLANTS WERE PLACED IN AN EDENTULOUS PATIENT AND THE TWO IMPLANTS BECAME LOOSE. THE IMPLANT WAS REMOVED ON (B)(6) 2013, DUE TO MOBILITY. MEDICAL HISTORY: PATIENT IS A SMOKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248963 MINIMARK DENTAL IMPLANT SYSTEM 2.3X10 W 2MM CUFF MINIMARK IMPLANT DZE ACE SURGICAL SUPPLY CO. 10231020 12020075

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention