BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KLOCKNER DENTAL IMPLANTS

    MDR report key: 540712 · Received August 19, 2004

    Report

    Report Number
    9617542-2004-00001
    Event Type
    Injury
    Date Received
    August 19, 2004
    Date of Event
    June 20, 2004
    Report Date
    August 13, 2004
    Manufacturer
    SOADCO, S.L.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    FAILED IMPLANT. PLACING OF AN IMPLANT AT POSITION 26 IN MAY AND JUNE LACK OF IRRIGATION AND SUBSEQUENT LOSS OF THIS, WHICH LED TO THE REPLACEMENT OF SAID FAILED IMPLANT BY ONE WITH A LARGER DIAMETER. ACCORDING TO STATEMENTS BY THE DOCTOR, POOR ADAPTATION OF THE MOVABLE PROSTHESIS BECAUSE THE IMPLANT REMOVED WAS 1 OF OTHER IMPLANTS PLACED DURING THE SAME PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KLOCKNER DENTAL IMPLANTS ENDO OSSEOUS DENTAL IMPLANT DZE SOADCO, S.L. SK2 3808 1253A 216

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other