BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NOBELPARALLEL CC NP 3.75X10MM

    MDR report key: 19802078 · Received July 22, 2024

    Report

    Report Number
    2027971-2024-104579
    Event Type
    Injury
    Date Received
    July 22, 2024
    Date of Event
    May 28, 2024
    Manufacturer
    NOBEL BIOCARE USA INC
    Product Code
    DZE
    UDI-DI
    07332747161205
    PMA / PMN Number
    K073142
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IMPLANT FAILED DUE TO A FAILURE TO OSSEOINTEGRATE 22.07.2024 10:35:14 CET (5001035) OSTEOMYELITIS WAS SELECTED AS A CONDITION INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2441030 NOBELPARALLEL CC NP 3.75X10MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE USA INC 13162661 07332747161205

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention