BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CM DRIVE IMPLANT 4.3X10 MM

    MDR report key: 4972021 · Received July 14, 2015

    Report

    Report Number
    3010593814-2015-00604
    Event Type
    Malfunction
    Date Received
    July 14, 2015
    Date of Event
    January 1, 2014
    Report Date
    January 28, 2015
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    (B)(4). THE DENTIST REPORTED 4 MONTHS AFTER THE DENTAL IMPLANT WAS INSTALLED IN INTRAORAL REGION #4 IT WAS VERIFIED ITS NON OSSEOINTEGRATION. 40 NCM OF PRIMARY STABILITY WAS ACHIEVED AND IMMEDIATE LOAD WAS NOT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458070 CM DRIVE IMPLANT 4.3X10 MM ENDOSSEOUS DENTAL IMPLANT DZE NA 800080003

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention