BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER DENTAL IMPLANT

    MDR report key: 11131748 · Received January 6, 2021

    Report

    Report Number
    MW5098717
    Event Type
    Injury
    Date Received
    January 6, 2021
    Date of Event
    July 15, 2020
    Report Date
    January 5, 2021
    Manufacturer
    ZIMMER DENTAL INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A ZIMMER DENTAL IMPLANT FAILED. PIECES OF THE IMPLANT/COLLAR BROKE OFF AND WERE LODGED IN THE BONE, CAUSING MOBILITY OF THE IMPLANT AND EXTENSIVE BONE LOSS AND TISSUE GRANULATION WHICH HAD TO BE DEBRIDED. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19310 ZIMMER DENTAL IMPLANT IMPLANT, ENDOSSEOUS, ROOT-FORM DZE ZIMMER DENTAL INC. HC465 4.5MM , 6.5MM X 5MM 62452480

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention