BEUDAMED
    FDA Adverse Event Other Summary report: N

    MICROLOK IMPLANT

    MDR report key: 509132 · Received January 14, 2004

    Report

    Report Number
    1045056-2003-00075
    Event Type
    Other
    Date Received
    January 14, 2004
    Date of Event
    November 20, 2003
    Report Date
    December 5, 2003
    Manufacturer
    BIO-LOK INTL., INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WAS ABOUT TO HAVE A FINAL CROWN PLACED ON IMPLANT, GENERAL DENTIST FELT ABOUT AND IMPLANT WAS LOOSE. SENT PATIENT TO TIGHTEN. ABUTMENT NOT LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MICROLOK IMPLANT ENDOSSEOUS DZE BIO-LOK INTL., INC. IITSS410D 3952A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other