BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY DENTAL IMPLANT

    MDR report key: 11746088 · Received April 29, 2021

    Report

    Report Number
    1287163-2021-00844
    Event Type
    Injury
    Date Received
    April 29, 2021
    Date of Event
    February 25, 2021
    Report Date
    April 29, 2021
    Manufacturer
    HAGER & MEISINGER GMBH
    Product Code
    DZE
    UDI-DI
    E0HM503310BL1
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IMPLANT LOSS SUGGESTS THAT THE SOURCE OF THE PROBLEM WAS LIKELY TO STEM FROM NO OSSEOINTEGRATION AND MOBILITY. ADDITIONALLY, OTHER FACTORS THAT MAY HAVE CONTRIBUTED TO THE IMPLANT FAILURE INCLUDES BONE CONDITION, PATIENT ORAL HYGIENE, OVERALL HEALTH OR BEHAVIOR. PROPER INTENDED USE OF THE IMPLANT IS DESCRIBED IN ITS INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    INADEQUATE BONE QUALITY/BONE QUANTITY, MOBILITY AND ASYMPTOMATIC WERE REPORTED. BONE QUALITY AT THE TIME OF IMPLANT FAILURE TYPE II. TIME OF LOSS IN RELATION TO THE IMPLANTATION WAS BEFORE PROSTHETIC RESTORATION. PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. AUGMENTATION PROCEDURE WAS NOT PERFORMED AT THE TIME OF SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641543 INFINITY DENTAL IMPLANT DENTAL IMPLANT DZE HAGER & MEISINGER GMBH 503310BL B59093 E0HM503310BL1

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention