BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACE SELECT TAPERED PMC RP 4.3X16MM

    MDR report key: 19365250 · Received May 21, 2024

    Report

    Report Number
    9611993-2024-073385
    Event Type
    Injury
    Date Received
    May 21, 2024
    Date of Event
    March 29, 2024
    Manufacturer
    NOBEL BIOCARE AB
    Product Code
    DZE
    UDI-DI
    07332747160895
    PMA / PMN Number
    K023113
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IMPLANT FAILED DUE TO A LOSS OF OSSEOINTEGRATION. (B)(6) 2024 15:31:53 CET (5023852). USER:5023852 RECEIVED DATE OF THE RETURN PRODUCT:21/05/2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1617295 REPLACE SELECT TAPERED PMC RP 4.3X16MM ENDOSSEOUS DENTAL IMPLANT DZE NOBEL BIOCARE AB 12148341 07332747160895

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Required Intervention