BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSSEOUS DENTAL IMPLANT

    MDR report key: 17516352 · Received August 11, 2023

    Report

    Report Number
    MW5123301
    Event Type
    Malfunction
    Date Received
    August 11, 2023
    Report Date
    November 13, 2017
    Manufacturer
    UNKNOWN
    Product Code
    DZE
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    WE HAVE RECEIVED A REPORT OF ONE IMPLANT OSSEOFAILURE FOR THE ABOVE PATIENT. THIS IMPLANT WAS REPORTED AS A NOBEL BIOCARE PART. HOWEVER, UPON RECEIPT OF THE IMPLANT AND FURTHER EVALUATION, IT WAS DETERMINED THAT THE IMPLANT WAS NOT MANUFACTURED BY NOBEL BIOCARE. NOBEL BIOCARE WAS UNABLE TO DETERMINE THE MANUFACTURER OF THIS IMPLANT. 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
    2192578 ENDOSSEOUS DENTAL IMPLANT IMPLANT, ENDOSSEOUS, ROOT-FORM DZE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown