BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIA400 IMPLANT 4MM W ABUTMENT 12MM

    MDR report key: 6123372 · Received November 22, 2016

    Report

    Report Number
    6000034-2016-02323
    Event Type
    Injury
    Date Received
    November 22, 2016
    Report Date
    November 9, 2016
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    PMA / PMN Number
    K121317
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED ON NOVEMBER 23, 2016. (B)(4). IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION, RESULTING IN FIXTURE LOSS. RE-IMPLANTATION IS PLANNED BUT HAD NOT TAKEN PLACE AT THE TIME OF THIS REPORT, NOVEMBER 23, 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772445 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