BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY INTERNAL HEXAGON DENTAL IMPLANT SYSTEM

    MDR report key: 4904995 · Received July 8, 2015

    Report

    Report Number
    1287163-2015-00058
    Event Type
    Injury
    Date Received
    July 8, 2015
    Date of Event
    February 13, 2015
    Report Date
    July 8, 2015
    Manufacturer
    ACE SURGICAL SUPPLY CO., INC.
    Product Code
    DZE
    PMA / PMN Number
    K102981
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE IMPLANT DETERMINED THAT ALL THE PRODUCT'S DESIGN SPECIFICATIONS WERE MET. VISUAL EXAMINATION YIELDED NO UNUSUAL OR SPECIFIC FLAWS TO THE IMPLANT DESIGN. THE REPORTED EVENT HAS BEEN DETERMINED TO BE A PRE LOADING IMPLANT FAILURE. EARLY IMPLANT LOSSES SUGGESTS THAT THE SOURCE OF THE PROBLEM IS LIKELY TO STEM FROM PROCEDURAL ERRORS AND/OR LACK OF OSSEOINTEGRATION. THE LOSS OF INTEGRATION OR THE NON-INTEGRATION OF AN ENDOSSEOUS DENTAL IMPLANT IS A KNOWN INHERENT RISK OF THE PROCEDURE. PATIENT MEDICAL HISTORY IS THOROUGHLY TO BE ASSESSED PRIOR TO PROCEDURE AS DESCRIBED IN THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    IMPLANT FAILED BEFORE PROSTHETIC RESTORATION. OSSEOINTEGRATION WAS ACHIEVED BUT UNKNOWN IF STABILITY WAS ACHIEVED. AT TIME OF IMPLANT FAILURE, SWELLING OCCURRED. BONE QUALITY WAS TYPE III.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444408 INFINITY INTERNAL HEXAGON DENTAL IMPLANT SYSTEM INFINITY INTERNAL HEXAGON DZE ACE SURGICAL SUPPLY CO., INC. 204713 13030091

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention