BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 1080868 · Received July 11, 2008

    Report

    Report Number
    MW5007771
    Event Type
    Other
    Date Received
    July 11, 2008
    Report Date
    July 11, 2008
    Manufacturer
    NOBEL BIOCARE USA
    Product Code
    DZE
    Report Source
    Voluntary report
    Reporter Location
    LU
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NOBEL BIOCARE USA HAS RECEIVED A REPORT OF AN OSSEOFAILURE FOR ONE IMPLANT REPORTED INACCURATELY AS NOBEL BIOCARE PART # 32207, LOT# 656388. HOWEVER, NOBEL BIOCARE DID NOT MFR THE RETURNED IMPLANT. IT IS REQUIRED THAT THE LOSS BE REPORTED TO THE FDA. NOBEL BIOCARE HAS DETERMINED THE IMPLANT TO BE MOST LIKELY MANUFACTURED 3I IMPLANT INNOVATIONS, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE DZE NOBEL BIOCARE USA 656388

    Patients

    Seq Age Sex Outcome Treatment
    1