BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENESIS IMPLANT SYSTEM

    MDR report key: 17653361 · Received August 29, 2023

    Report

    Report Number
    MW5145086
    Event Type
    Malfunction
    Date Received
    August 29, 2023
    Report Date
    August 24, 2023
    Manufacturer
    KEYSTONE DENTAL, INC.
    Product Code
    DZE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    IMPLANT WAS PLACED AND REMOVED THE SAME DAY. IT WAS REPLACED WITH A LARGER IMPLANT 31. WAS AUGMENTATION PERFORMED DURING SURGERY? NO. WAS A MEMBRANE USED? NO. AT THE TIME OF THE EVENT OR IMPLANT FAILURE/REMOVAL. WAS THERE, OTHER: LARGER IMPLANT WAS PLACED. DISCLAIMER STATEMENT: THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1438948 GENESIS IMPLANT SYSTEM IMPLANT, ENDOSSEOUS, ROOT-FORM DZE KEYSTONE DENTAL, INC. G21145 WO 023424

    Patients

    Seq Age Sex Outcome Treatment
    1 Female