BEUDAMED
    FDA Adverse Event Other Summary report: N

    NONE

    MDR report key: 1080867 · Received July 11, 2008

    Report

    Report Number
    MW5007770
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NOBEL BIOCARE USA, LLC, HAS REC'D AN INACCURATE REPORT OF AN IMPLANT FAILURE FOR ONE IMPLANT: PART # 32148/LOT # 662431. THIS IS A NOBEL BIOCARE IMPLANT PART NUMBER, HOWEVER, THIS IS NOT A NOBEL BIOCARE MANUFACTURED IMPLANT. IT WAS DETERMINED THAT ZIMMER DENTAL MOST LIKELY MANUFACTURED THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE DZE NOBEL BIOCARE USA 662431

    Patients

    Seq Age Sex Outcome Treatment
    1