BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY DENTAL IMPLANT SYSTEM

    MDR report key: 3181574 · Received June 17, 2013

    Report

    Report Number
    1287163-2013-00056
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    March 28, 2013
    Report Date
    June 10, 2013
    Manufacturer
    ACE SURGICAL SUPPLY CO.
    Product Code
    DZE
    PMA / PMN Number
    K103790
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    REMOVAL OF ENDOSSEIOUS DENTAL IMPLANT. IMPLANT WAS PLACED ON (B)(6) 2013 IN SITE #13 (TYPE II BONE). PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. THE CLINICIAN STATES THAT THE IMPLANT WAS NOT OSSEOINTEGRATED AND SPINNING. THE IMPLANT WAS REMOVED ON (B)(6) 2013 DUE TO MOBILITY. MEDICAL HISTORY: NO SIGNIFICANT FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273128 INFINITY DENTAL IMPLANT SYSTEM TRI CAM DENTAL IMPLANT DZE ACE SURGICAL SUPPLY CO. 304308 12030097

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention