BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIA400 IMPLANT 4MM W ABUTMENT 12MM

    MDR report key: 11874335 · Received May 25, 2021

    Report

    Report Number
    6000034-2021-01683
    Event Type
    Injury
    Date Received
    May 25, 2021
    Report Date
    May 27, 2021
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    PMA / PMN Number
    K121317
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THE PREVIOUS OR INITIAL MDR SUBMITTED ON MAY 25, 2021, WAS FILED INADVERTENTLY. THERE WAS NO CONVERSION TO A TRANSCUTANEOUS OSIA IMPLANT SYSTEM FOR THE CURRENT DEVICE. THE OSIA IMPLANT SYSTEM WAS IMPLANTED AT A NEW SITE. THIS REPORT IS SUBMITTED ON JUNE 22, 2021.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON MAY 25, 2021.

    Description of Event or Problem · 1

    AS PER THE CLINIC, THE ABUTMENT WAS REMOVED AND REPLACE WITH AN OSIA DEVICE (DATE AND REASON FOR THE CONVERSION UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776104 BIA400 IMPLANT 4MM W ABUTMENT 12MM COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB 93332

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention