BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANT, ENDOSSEOUS, ROOT-FORM

    MDR report key: 17516164 · Received August 11, 2023

    Report

    Report Number
    MW5123113
    Event Type
    Injury
    Date Received
    August 11, 2023
    Report Date
    December 19, 2012
    Manufacturer
    UNKNOWN
    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 TWO IMPLANT OSSEOFAILURES: THE IMPLANTS RETURNED FOR THIS REPORT ARE NOT NOBEL BIOCARE IMPLANTS AND, PER 21 CFR 803.22, IT IS REQUIRED THAT THE LOSS BE REPORTED TO THE FDA. NOBEL BIOCARE WAS UNABLE TO DETERMINE THE MANUFACTURER OF THESE IMPLANTS. (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
    563417 IMPLANT, ENDOSSEOUS, ROOT-FORM IMPLANT, ENDOSSEOUS, ROOT-FORM DZE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown