BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIA400 IMPLANT 4MM W ABUTMENT 8MM

    MDR report key: 10156165 · Received June 15, 2020

    Report

    Report Number
    6000034-2020-01456
    Event Type
    Injury
    Date Received
    June 15, 2020
    Date of Event
    May 26, 2020
    Report Date
    May 20, 2020
    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 JUNE 15, 2020.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE ABUTMENT SITE THAT WAS TREATED WITH ORAL ANTIBIOTICS. THE ABUTMENT WAS CHANGED UNDER A GENERAL ANAESTHETIC ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619742 BIA400 IMPLANT 4MM W ABUTMENT 8MM COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB 93330 COH1291726

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention