BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE ST 4MM W. BAHA ABUTMENT

    MDR report key: 6019605 · Received October 11, 2016

    Report

    Report Number
    6000034-2016-02040
    Event Type
    Injury
    Date Received
    October 11, 2016
    Report Date
    October 24, 2016
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 0

    REGISTRATION NUMBER 3009092818 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 UNDERWENT REVISION SURGERY (DATE NOT REPORTED), IN ORDER TO PLACE AN INTERNAL MAGNET.

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2015, IN ORDER TO PLACE AN INTERNAL MAGNET. CORRECTION: THE CORRECT IMPLANTED DATE IS, (B)(6) 2007; NOT (B)(6) 2015 AS PREVIOUSLY REPORTED. THE CORRECT CATALOG # IS, 90434; NOT 92129 AS PREVIOUSLY REPORTED. THE LOT # IS UNKNOWN. THE CORRECT PMA/510(K) IS, K955713; NOT K100360 AS PREVIOUSLY REPORTED. (B)(4). IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669956 FLANGE FIXTURE ST 4MM W. BAHA ABUTMENT COCHLEAR BAHA CONNECT SYSTEM LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 90434 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention