BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIA400 IMPLANT 4MM W ABUTMENT 10MM

    MDR report key: 8978021 · Received September 9, 2019

    Report

    Report Number
    6000034-2019-01708
    Event Type
    Injury
    Date Received
    September 9, 2019
    Report Date
    August 20, 2019
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    UDI-DI
    09321502022712
    PMA / PMN Number
    K121317
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON SEPTEMBER 09, 2019, BY COCHLEAR LTD.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH ON THE ABUTMENT. SUBSEQUENTLY, THE ABUTMENT WAS REMOVED UNDER A GENERAL ANAESTHETIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768401 BIA400 IMPLANT 4MM W ABUTMENT 10MM COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB 93331 COH1090682 09321502022712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention