BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIXED ABUTMENT: PREANGLED, 15 DEGREE, 2MM, OMNILOC, 4.0

    MDR report key: 150494 · Received February 24, 1998

    Report

    Report Number
    2023141-1998-00070
    Event Type
    Injury
    Date Received
    February 24, 1998
    Date of Event
    May 15, 1997
    Report Date
    January 27, 1998
    Manufacturer
    SULZER CALCITEK
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DISTRIBUTOR REPORTED THAT AN ABUTMENT BROKE IN FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FIXED ABUTMENT: PREANGLED, 15 DEGREE, 2MM, OMNILOC, 4.0 Implant CEMENT RETAINED DENTAL ABUTMENT DZE SULZER CALCITEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention