BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACE SELECT TAPERED PMC RP 4.3X11.5MM

    MDR report key: 22958370 · Received September 3, 2025

    Report

    Report Number
    9611993-2025-122765
    Event Type
    Injury
    Date Received
    September 3, 2025
    Date of Event
    June 30, 2025
    Manufacturer
    NOBEL BIOCARE AB GÖTEBORG
    Product Code
    DZE
    UDI-DI
    07332747160871
    PMA / PMN Number
    K023113
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    LOSS OFO SSEOINTEGRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1293377 REPLACE SELECT TAPERED PMC RP 4.3X11.5MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB GÖTEBORG 13185660 07332747160871

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention