BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT, ENDOSSEOUS, ROOT-FORM

    MDR report key: 20160673 · Received September 5, 2024

    Report

    Report Number
    MW5159296
    Event Type
    Injury
    Date Received
    September 5, 2024
    Report Date
    August 28, 2024
    Manufacturer
    HIOSSEN INC.
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    PERI-IMPLANTITIS, INFECTION, MOBILITY, BLEEDING. 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
    1536397 IMPLANT, ENDOSSEOUS, ROOT-FORM IMPLANT, ENDOSSEOUS, ROOT-FORM DZE HIOSSEN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female