BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELPARALLEL CC RP 5.0X11.5MM

    MDR report key: 11808271 · Received May 11, 2021

    Report

    Report Number
    2027971-2021-70123
    Event Type
    Injury
    Date Received
    May 11, 2021
    Date of Event
    May 4, 2021
    Manufacturer
    NOBEL BIOCARE USA INC
    Product Code
    DZE
    UDI-DI
    7332747091595
    PMA / PMN Number
    K073142
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IMPLANT FAILED DUE TO UNCONFIRMED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700461 NOBELPARALLEL CC RP 5.0X11.5MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE USA INC 13093059 7332747091595

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention