BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIA400 IMPLANT 4MM W ABUTMENT 10MM

    MDR report key: 9584689 · Received January 14, 2020

    Report

    Report Number
    6000034-2020-00047
    Event Type
    Injury
    Date Received
    January 14, 2020
    Report Date
    December 23, 2019
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON JANUARY 14, 2020.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED INFLAMMATION AND FLUID DRAINAGE AT THE ABUTMENT SITE THAT WAS TREATED WITH A TOPICAL ANTIBIOTIC. THE IMPLANT REMAINS IN-SITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48231 BIA400 IMPLANT 4MM W ABUTMENT 10MM COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB 93331

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention