BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DENTAL IMPLANT

    MDR report key: 25085324 · Received May 4, 2026

    Report

    Report Number
    MW5187656
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Report Date
    April 23, 2026
    Manufacturer
    UNK
    Product Code
    DZB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ASSESSMENT OF HYGIENE AROUND IMPLANT: GOOD. PERI-IMPLANTITIS. PREVIOUS BONE AUGMENTATION. INFECTION, MOBILITY, ASYMPTOMATIC. "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
    564094 DENTAL IMPLANT HEADGEAR, EXTRAORAL, ORTHODONTIC DZB UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male