BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ¿ IMPLANT

    MDR report key: 14845196 · Received June 28, 2022

    Report

    Report Number
    2027971-2022-084757
    Event Type
    Injury
    Date Received
    June 28, 2022
    Date of Event
    June 9, 2022
    Report Date
    June 28, 2022
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE IMPLANT MALFUNCTIONED DUE TO DROPPING FROM THE IMPLANT DRIVER. THE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 0

    THE INITIAL REPORT DID NOT HAVE THE CORRECT EVENT TYPE DOCUMENTED, THE CORRECT EVENT TYPE, SERIOUS INJURY, IS PROVIDED IN THIS FOLLOW-UP REPORT. (B)(6)2022 11:04:47 CET (5010074) IMPLANT FAILED DUE TO AN OSSEOINTEGRATION PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2044454 UNKNOWN ¿ IMPLANT ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention