BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASTRA TECH

    MDR report key: 2081803 · Received May 5, 2011

    Report

    Report Number
    MW5020501
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    August 20, 2007
    Report Date
    April 27, 2011
    Manufacturer
    ASTRA
    Product Code
    DZE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    FRACTURED ASTRA DENTAL IMPLANT. APPROXIMATELY 1/2 OF THE IMPLANT REMAINED INTEGRATED IN THE BONE. FRACTURED APPROXIMATELY 2 YEARS AFTER PLACEMENT. DATES OF USE: 2005 - 2007. DIAGNOSIS OR REASON FOR USE: MISSING TOOTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASTRA TECH ASTRA TECH DENTAL IMPLANT DZE ASTRA 4.5 X 11MM 25154

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Disability