BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KLOCKNER DENTAL IMPLANTS

    MDR report key: 540704 · Received August 19, 2004

    Report

    Report Number
    9617542-2004-00003
    Event Type
    Injury
    Date Received
    August 19, 2004
    Date of Event
    May 3, 2004
    Report Date
    August 16, 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

    THE IMPLANT REMOVED WAS 1 OF 4 IMPLANTS PLACED DURING THE SAME PROCEDURE IN THE 34, 35 AND 37 TOOTH SITES. THE IMPLANT REMOVED WAS IN THE 36 SITE. WHEN AN ATTEMPT WAS MADE TO REMOVE THE SCREW HOLDING IN PLACE THE HEXAGONAL TRANSFER (TAKING THE IMPRINT), THE IMPLANT CAME OUT TOGETHER WITH THE TRANSFER ACCORDING TO STATEMENTS BY THE DR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KLOCKNER DENTAL IMPLANTS ENDOSSEOUS DENTAL IMPLANT DZE SOADCO, S.L. SK2 4212 1958 A 245

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other