BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMARK DENTAL IMPLANT SYSTEM

    MDR report key: 3252214 · Received July 25, 2013

    Report

    Report Number
    1287163-2013-00081
    Event Type
    Injury
    Date Received
    July 25, 2013
    Date of Event
    June 27, 2013
    Report Date
    July 22, 2013
    Manufacturer
    ACE SURGICAL SUPPLY CO.
    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) 2013 IN SITE AREA #6 (TYPE III BONE). PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. IMMEDIATE LOAD OF THE IMPLANT AT THE TIME OF SURGERY WAS INVOLVED. THE CLINICIAN STATES THAT THE IMPLANT DID NOT INTEGRATE. THE IMPLANT WAS REMOVED ON (B)(6) 2013 DUE TO PAIN, BLEEDING, MOBILITY. MED. HISTORY: JOINT REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348675 MINIMARK DENTAL IMPLANT SYSTEM 2.9X10MM W 2MM CUFF MINIMARK IMPLANT DZE ACE SURGICAL SUPPLY CO. 10321020 12020084

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention