BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CM ALVIM IMPLANT 3.5X10 MM

    MDR report key: 4972132 · Received July 14, 2015

    Report

    Report Number
    3010593814-2015-00710
    Event Type
    Malfunction
    Date Received
    July 14, 2015
    Date of Event
    December 8, 2014
    Report Date
    January 30, 2015
    Manufacturer
    AVENIDA JUSCELINO KUBITSCHEK DE OLIVEIRA, 3291 CIC
    Product Code
    DZE
    PMA / PMN Number
    K101945
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE DENTIST REPORTED 2 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #5 IT WAS VERIFIED ITS NON OSSEOINTEGRATION. 60 NCM OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS PERFORMED. BONE GRAFT WAS EXECUTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457973 CM ALVIM IMPLANT 3.5X10 MM ENDOSSEOUS DENTAL IMPLANT DZE AVENIDA JUSCELINO KUBITSCHEK DE OLIVEIRA, 3291 CIC NA 800087962

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention