BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINITY DENTAL IMPLANT SYSTEM

    MDR report key: 3020614 · Received March 21, 2013

    Report

    Report Number
    1287163-2013-00026
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 18, 2013
    Manufacturer
    ACE SURGICAL SUPPLY CO., INC.
    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 ENDOSSEOUS DENTAL IMPLANT. IMPLANT WAS PLACED ON (B)(6) 2012 AT SITE #19 (TYPE II BONE). PRIMARY STABILITY WAS ACHIEVED. OSSEOINTEGRATION WAS NOT ACHIEVED. THE CLINICIAN STATES THAT THE PT HAD TO WAIT ALMOST A YEAR BEFORE SHE WAS FINANCIALLY ABLE TO RESTORE THE IMPLANT. THE CLINICIAN REPORTS THA THE HEALING ABUTMENT CAME LOOSE AND THE PT WAS UNAWARE OF IT. THEREFORE, AN INFECTION SET IN AROUND THE IMPLANT CAUSING THE IMPLANT TO BECOME LOOSE. THE IMPLANT WAS REMOVED ON (B)(6) 2013 DUE TO INFECTION, MOBILITY. MEDICAL HISTORY: NO SIGNIFICANT FINDINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118907 INFINITY DENTAL IMPLANT SYSTEM TRI CAM DENTAL IMPLANT DZE ACE SURGICAL SUPPLY CO., INC. 305008 11090019

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention