BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMARK DENTAL IMPLANT SYSTEM

    MDR report key: 3152570 · Received June 5, 2013

    Report

    Report Number
    1287163-2013-00053
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    April 22, 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
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    REMOVAL OF ENDOSSEOUS DENTAL IMPLANT. IMPLANT WAS PLACED ON (B)(6) 2013 (TYPE I BONE) IN SITE (B)(6). THE CLINICIAN STATES THAT THE IMPLANTS FRACTURED DURING THE PLACEMENT OF THE IMPLANT. THE IMPLANT WAS REMOVED ON (B)(6) 2013. ANOTHER IMPLANT WAS NOT PLACED DURING THE SURGICAL PROCEDURE. MED. HISTORY: NO SIGNIFICANT FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247666 MINIMARK DENTAL IMPLANT SYSTEM 2.3X13 W 2MM CUFF MINIMARK IMPLANT DZE ACE SURGICAL SUPPLY CO. 10231320 12020081

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention