BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIA400 IMPLANT 4MM W ABUTMENT 10MM

    MDR report key: 6108207 · Received November 16, 2016

    Report

    Report Number
    6000034-2016-02293
    Event Type
    Injury
    Date Received
    November 16, 2016
    Date of Event
    October 24, 2016
    Report Date
    November 8, 2016
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    PMA / PMN Number
    K121317
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS FILED ON NOVEMBER 17, 2016. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    PER THE PATIENT'S SURGEON, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION ON (B)(6) 2016, RESULTING IN FIXTURE LOSS. RE-IMPLANTATION IS PLANNED BUT HAS NOT OCCURRED AS OF THE DATE OF THIS REPORT NOVEMBER 17, 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758025 BIA400 IMPLANT 4MM W ABUTMENT 10MM COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB 93331 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention