BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENTAL IMPLANT

    MDR report key: 16279040 · Received January 31, 2023

    Report

    Report Number
    MW5114619
    Event Type
    Malfunction
    Date Received
    January 31, 2023
    Date of Event
    December 27, 2022
    Report Date
    January 30, 2023
    Manufacturer
    STRAUMANN MANUFACTURING, INC.
    Product Code
    DZE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAD AN IMPLANT PLACED IN TOOTH #5 ON (B)(6) 2021. THE MANUFACTURER IS STRAUMANN, PLATFORM DIAMETER 4.5MM, LENGTH IS 8MM, AND STYLE IS BLX/RB. IN (B)(6) OF 2022, MY ABUTMENT SCREW BROKE AND NOW IT IS STUCK AND IRRETRIEVABLE FROM MY IMPLANT, ALTHOUGH MANY ATTEMPTS WERE MADE ON (B)(6) 2023 BY EXPERT PERIODONTISTS. THIS NOW ULTIMATELY MAKES MY IMPLANT UNUSABLE. I HAVE BEEN RECOMMENDED TO EXTRACT THE IMPLANT AND REDO THE IMPLANT PROCEDURE AS WELL AS THE POST ABUTMENT AND CROWN PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903154 DENTAL IMPLANT IMPLANT, ENDOSSEOUS, ROOT-FORM DZE STRAUMANN MANUFACTURING, INC. AFV08

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Female Other FISH OIL| VITAMIN B COMPLEX| VITAMIN D| WOMEN'S ONE A DAY