BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DENTAL IMPLANT

    MDR report key: 11632554 · Received April 8, 2021

    Report

    Report Number
    3001617766-2021-02023
    Event Type
    Injury
    Date Received
    April 8, 2021
    Date of Event
    March 22, 2021
    Report Date
    April 7, 2021
    Manufacturer
    IMPLANT DIRECT SYBRON MANUFACTURING LLC
    Product Code
    DZE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S IDENTIFIER, AGE, SEX, WEIGHT WERE NOT PROVIDED. WHEN THE REQUESTED INFORMATION BECOMES AVAILABLE, A SUPPLEMENTARY REPORT WILL BE SUBMITTED. LOT AND PART INFORMATION ARE UNKNOWN. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A SUPPLEMENTARY REPORT WILL BE SUBMITTED. DEVICE EVALUATION RESULTS ARE NOT AVAILABLE. WHEN THE ANALYSIS IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PMA/510(K) - NOT APPLICABLE.

    Description of Event or Problem · 1

    PER COMPLAINT (B)(4), AFTER CLINICAL PROCEDURE, PATIENT EXPERIENCED FAILURE OF IMPLANT TO INTEGRATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530814 DENTAL IMPLANT DZE IMPLANT DIRECT SYBRON MANUFACTURING LLC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention