BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINMARK DENTAL IMPLANT SYSTEM

    MDR report key: 3213811 · Received July 3, 2013

    Report

    Report Number
    1287163-2013-00069
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    December 27, 2012
    Report Date
    June 28, 2013
    Manufacturer
    ACE SURGICAL SUPPLY CO.
    Product Code
    DZE
    PMA / PMN Number
    K092594
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. IMPLANT WAS PLACED ON (B)(6) 2012 IN SITE #31(TYPE II BONE). PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. A PREVIOUS BONE GRAFT WAS PERFORMED ON (B)(6) 2011 USING NUOSS 2.0 PARTICULATE. THE CLINICIAN REPORTS THE REASON FOR THE IMPLANT FAILURE WAS LACK OF OSSEOINTEGRATION. THE IMPLANT WAS REMOVED ON (B)(6) 2011 DUE TO MOBILITY. MED. HISTORY: NO SIGNIFICANT FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303868 MINMARK DENTAL IMPLANT SYSTEM 2.3X11.5 W 2MM CUFF MINIMARK IMPLANT DZE ACE SURGICAL SUPPLY CO. 11231100 11050002

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention