BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT OSSEOFAILURE

    MDR report key: 17516512 · Received August 11, 2023

    Report

    Report Number
    MW5123461
    Event Type
    Injury
    Date Received
    August 11, 2023
    Report Date
    June 12, 2017
    Manufacturer
    IMPLANT DIRECT, LLC
    Product Code
    DZE
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    NOBEL BIOCARE USA HAS RECEIVED A REPORT OF AN OSSEOFAILURE FOR TWO IMPLANTS; ARTICLE # AND LOT # UNKNOWN. THESE ARE NOT NOBEL BIOCARE IMPLANTS, BUT PER ?21 CFR 803.22, IT IS REQUIRED THAT THE LOSSES BE REPORTED TO THE FDA. IT IS BELIEVED THAT THE IMPLANTS ARE MANUFACTURED BY IMPLANT DIRECT, LLC 8108117 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
    762384 IMPLANT OSSEOFAILURE IMPLANT, ENDOSSEOUS, ROOT-FORM DZE IMPLANT DIRECT, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown