BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTAL ABUTMENT

    MDR report key: 19894380 · Received August 1, 2024

    Report

    Report Number
    MW5157934
    Event Type
    Injury
    Date Received
    August 1, 2024
    Date of Event
    December 31, 2023
    Report Date
    July 30, 2024
    Manufacturer
    ZIMVIE/BIOMET 3I, LLC
    Product Code
    NHA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAD A PERMANENT DENTAL IMPLANT, LESS THAN 5 YEARS OLD, THAT THE ABUTMENT BROKE OFF IN MY MOUTH AND I ALMOST SWALLOWED IT. I HAD TO GO BACK TO MY DENTIST, WHO THEN SENT ME TO THE ORAL SURGEON WHO HAD TO REMOVE THE SCREW THAT WAS STILL IN THE IMPLANT IN MY JAW. THEN I HAD TO RETURN TO THE DENTIST TO FIT A NEW CROWN, WHICH I AM NOW EXPECTED TO PAY FOR. THE PROCESS TOOK MONTHS AND THE MANUFACTURER ZIMVIE IS NOT RESPONSIVE. PERMANENT ORAL IMPLANT. MODEL NUMBER; CATALOG NUMBER; LOT NUMBER; SERIAL NUMBER; AND UDI NUMBER: ALL UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384654 DENTAL ABUTMENT ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS NHA ZIMVIE/BIOMET 3I, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention FISH OIL.| PERMANENT DENTAL IMPLANT.