BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTRACT SYSTEM

    MDR report key: 5151246 · Received October 15, 2015

    Report

    Report Number
    6000034-2015-02069
    Event Type
    Injury
    Date Received
    October 15, 2015
    Report Date
    October 19, 2015
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K131240
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    (B)(6). CORRECTION: THE CORRECT BRAND NAME IS ATTRACT SYSTEM; NOT FLANGE FIXTURE AND ABUTMENT AS PREVIOUSLY REPORTED. CORRECTION: THE CORRECT CATALOG # IS 93332; NOT 93335 AS PREVIOUSLY REPORTED. CORRECTION: THE PMA # IS K131240; NOT K955713 AS PREVIOUSLY REPORTED. PER THE CLINIC, THE PATIENT EXPERIENCED SKIN BREAKDOWN RESULTING IN EXPOSURE OF THE INTERNAL MAGNET. SUBSEQUENTLY ON (B)(6) 2015 THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO HAVE THE INTERNAL MAGNET REMOVED. THE IMPLANTED DEVICE REMAINS. THIS REPORT IS FILED FEBRUARY 19, 2016.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION AT THE ABUTMENT SITE. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683983 ATTRACT SYSTEM LXB, PRODUCT CODE: LXB COCHLEAR BONE ANCHORED SOLUTIONS AB N/A 133316

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention