BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACE BL NP IMPLANT 3.3X10MM

    MDR report key: 11736623 · Received April 28, 2021

    Report

    Report Number
    8010516-2021-00026
    Event Type
    Injury
    Date Received
    April 28, 2021
    Date of Event
    December 17, 2020
    Report Date
    April 28, 2021
    Manufacturer
    HAGER & MEISINGER GMBH
    Product Code
    DZE
    UDI-DI
    E0HM220101
    PMA / PMN Number
    K143539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THE COMPLAINT WAS CARRIED OUT CONSIDERING THE ANALYSIS OF THE INFORMATION GIVEN BY THE DENTIST IN THE GUARANTEE FORM, VISUAL CONFERENCE OF THE PRODUCT RETURNED BY THE DENTIST AND THE EVALUATION OF RELEVANT PRODUCTION RECORDS.

    Description of Event or Problem · 1

    PRIMARY STABILITY WAS NOT ACHIEVED, A WIDER IMPLANT WAS SEATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638414 ACE BL NP IMPLANT 3.3X10MM DENTAL IMPLANT DZE HAGER & MEISINGER GMBH 3622010DU0ACE B91947 E0HM220101

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other