BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIA400 IMPLANT 4MM W ABUTMENT 12MM

    MDR report key: 6019353 · Received October 11, 2016

    Report

    Report Number
    6000034-2016-01978
    Event Type
    Injury
    Date Received
    October 11, 2016
    Report Date
    September 20, 2016
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    PMA / PMN Number
    K121317
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL IMPLANTATION DETAILS UNAVAILABLE AT THE TIME OF THIS REPORT. REGISTRATION NUMBER 3009092818 AND EXEMPTION NUMBER E2016011. THIS REPORT IS FILED ON OCTOBER 12, 2016. H3 OTHER TEXT: IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED INFECTION AT ABUTMENT SITE, CLINICAL MANAGEMENT IS ONGOING. THE IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    THE CORRECT BRAND NAME IS BIA400 IMPLANT 4MM W ABUTMENT 12MM, CORRECT COMMON DEVICE NAME IS COCHLEAR BAHA CONNECT SYSTEM AND PMA/510(K) IS K121317, NOT COCHLEAR BAHA CONNECT SYSTEM, COMMON DEVICE NAME LXB, PRODUCT CODE: LXB AS PREVIOUSLY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667961 BIA400 IMPLANT 4MM W ABUTMENT 12MM COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB 93332 158806

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention