BEUDAMED
    FDA Adverse Event Other Summary report: N

    MIRCO-LOK IMPLANT

    MDR report key: 169658 · Received April 27, 1998

    Report

    Report Number
    1045056-1998-00041
    Event Type
    Other
    Date Received
    April 27, 1998
    Date of Event
    February 17, 1998
    Report Date
    March 19, 1998
    Manufacturer
    BIO-LOK INTERNATIONAL
    Product Code
    DZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    TWO IMPLANTS FAILED TO OSSEOINTEGRATE DUE TO FIBEROUS ENCAPSULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MIRCO-LOK IMPLANT Implant CYLINDER IMPLANTS DZE BIO-LOK INTERNATIONAL IHCSHA410 9608033795

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other