BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELREPLACE TAPERED GROOVY WP 5X10MM

    MDR report key: 11909568 · Received May 31, 2021

    Report

    Report Number
    2027971-2021-76072
    Event Type
    Injury
    Date Received
    May 31, 2021
    Date of Event
    April 7, 2021
    Manufacturer
    NOBEL BIOCARE USA INC
    Product Code
    DZE
    UDI-DI
    7332747001884
    PMA / PMN Number
    K050258
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804978 NOBELREPLACE TAPERED GROOVY WP 5X10MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE USA INC 473158 7332747001884

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention