BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTAL IMPLANTS

    MDR report key: 25166814 · Received May 13, 2026

    Report

    Report Number
    MW5188164
    Event Type
    Injury
    Date Received
    May 13, 2026
    Report Date
    May 8, 2026
    Manufacturer
    SOUTHERN IMPLANTS (PTY) LTD
    Product Code
    DZE
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE (B)(6) REGULATORY DEPARTMENT HAS RECEIVED FOUR WARRANTY CLAIMS REPORTING FAILED IMPLANTS NOT MANUFACTURED OR DISTRIBUTED BY THE (B)(6). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REF: MW5188163, MW5188165, MW5188166.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284086 DENTAL IMPLANTS IMPLANT, ENDOSSEOUS, ROOT-FORM DZE SOUTHERN IMPLANTS (PTY) LTD 31640101

    Patients

    Seq Age Sex Outcome Treatment
    1