BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANT, ENDOSSEOUS, ROOT-FORM

    MDR report key: 17529163 · Received August 12, 2023

    Report

    Report Number
    MW5136092
    Event Type
    Malfunction
    Date Received
    August 12, 2023
    Date of Event
    October 7, 2022
    Report Date
    October 21, 2022
    Manufacturer
    BIOMET 3I, LLC
    Product Code
    DZE
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    LOSS OF INTEGRATION. IMPLANT BECAME LOOSE. NO PATIENT IMPACT. (B)(4). 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
    564232 IMPLANT, ENDOSSEOUS, ROOT-FORM IMPLANT, ENDOSSEOUS, ROOT-FORM DZE BIOMET 3I, LLC BOPT4311

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown