BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM

    MDR report key: 17840220 · Received September 28, 2023

    Report

    Report Number
    0002023141-2023-02669
    Event Type
    Malfunction
    Date Received
    September 28, 2023
    Date of Event
    June 15, 2023
    Report Date
    September 27, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019508
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). E1: REPORTER EMAIL ADDRESS UNKNOWN / NOT PROVIDED. G4: PREMARKET IDENTIFICATION K011028/K013227.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PROCEDURE , WHEN OPENING THE BLISTER THE DOCTOR REALIZED THAT THE INNER TUBE WAS NOT CORRECTLY SEALED, SEEMED TO BE OPENED. HE DECIDED NOT TO PLACE THE IMPLANT AND REPLACE IT BY ANOTHER ONE IN STOCK. TOOTH LOCATION 45.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2098778 IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL 1258040 00889024019508

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female