BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 1080861 · Received July 8, 2008

    Report

    Report Number
    MW5007764
    Event Type
    Other
    Date Received
    July 8, 2008
    Report Date
    July 8, 2008
    Manufacturer
    NOBEL BIOCARE USA
    Product Code
    DZE
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NOBEL BIOCARE USA HAS REC'D A REPORT OF AN OSSEOFAILURE FOR ONE IMPLANT INACCURATELY REPORTED AS PART # 32220, LOT # 380146. NOBEL BIOCARE DOES NOT MANUFACTURER 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 BY BIOHORIZONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE DZE NOBEL BIOCARE USA 380146

    Patients

    Seq Age Sex Outcome Treatment
    1