BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIA400 IMPLANT 4MM W ABUTMENT 12MM

    MDR report key: 10446754 · Received August 25, 2020

    Report

    Report Number
    6000034-2020-02222
    Event Type
    Injury
    Date Received
    August 25, 2020
    Report Date
    August 4, 2020
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    UDI-DI
    09321502022729
    PMA / PMN Number
    K121317
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON AUGUST 25, 2020.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AT THE ABUTMENT SITE, AND WAS TREATED WITH AN ANTIBIOTIC OINTMENT (SPECIFIC DATE NOT REPORTED). THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913291 BIA400 IMPLANT 4MM W ABUTMENT 12MM COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB 93332 COH1237074 09321502022729

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention