BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 1080863 · Received July 9, 2008

    Report

    Report Number
    MW5007766
    Event Type
    Other
    Date Received
    July 9, 2008
    Report Date
    July 9, 2008
    Manufacturer
    NOBEL BIOCARE USA
    Product Code
    DZE
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NOBEL BIOCARE USA HAS RECEIVED A REPORT OF AN OSSEOFAILURE FOR ONE IMPLANT PART # UNKNOWN LOT # UNKNOWN. NOBEL BIOCARE DID NOT MANUFACTURE THE IMPLANT RETURNED. PER SECTION 21 CFR 803. 22, IT IS REQUIRED THAT THE LOSS BE REPORTED TO THE FDA. NOBEL BIOCARE HAS DETERMINED IMPLANT DIRECT, LLC, MOST LIKELY MANUFACTURED THIS IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE DZE NOBEL BIOCARE USA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1