BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENTAL IMPLANT

    MDR report key: 20629659 · Received November 5, 2024

    Report

    Report Number
    MW5162258
    Event Type
    Malfunction
    Date Received
    November 5, 2024
    Report Date
    October 30, 2024
    Manufacturer
    BIOHORIZONS IMPLANT SYSTEMS INC.
    Product Code
    DZE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    REPORT OF ADVERSE EVENT INFORMATION ABOUT A DEVICE THAT WAS NOT MANUFACTURED OR IMPORTED BY THE (B)(6). PRIMARY STABILITY NOT ACHIEVED. 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
    1875755 DENTAL IMPLANT IMPLANT, ENDOSSEOUS, ROOT-FORM DZE BIOHORIZONS IMPLANT SYSTEMS INC. 2403126

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female