BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NOBELPARALLEL CC NP 3.75X11.5MM

    MDR report key: 20604266 · Received November 4, 2024

    Report

    Report Number
    9611993-2024-122915
    Event Type
    Malfunction
    Date Received
    November 4, 2024
    Date of Event
    October 2, 2024
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    UDI-DI
    07332747161212
    PMA / PMN Number
    K173418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IMPLANT FAILED DUE TO COMPONENT NOT RETAINED ON MATING PART. (B)(6) 2024 13:36:20 CET (5020889) CORRECTION THE IMPLANT MALFUNCTIONED DUE TO COMPONENT NOT RETAINED ON MATING PART. THE MALFUNCTION DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78114 NOBELPARALLEL CC NP 3.75X11.5MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB 12246534 07332747161212

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention