BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BA300 ABUTMENT 9MM

    MDR report key: 5400938 · Received January 31, 2016

    Report

    Report Number
    6000034-2016-00282
    Event Type
    Injury
    Date Received
    January 31, 2016
    Date of Event
    January 19, 2016
    Report Date
    November 22, 2016
    Manufacturer
    COCHLEAR BONE ANCHORED SYSTEM AB
    Product Code
    LXB
    PMA / PMN Number
    K100360
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT FILED FEBRUARY 1ST, 2016. DEVICE NOT RECEIVED BY MANUFACTURER.

    Additional Manufacturer Narrative · 1

    CORRECTION: THE CORRECT BRAND NAME IS: 'BA300 ABUTMENT 9MM', NOT 'FLANGE FIXTURE AND ABUTMENT' AS PREVIOUSLY REPORTED. THE CORRECT COMMON DEVICE NAME IS: COCHLEAR BAHA CONNECT SYSTEM, NOT 'LXB' AS PREVIOUSLY REPORTED. THE CORRECT CATALOG # IS: 92131, NOT '92127' AS INITIALLY REPORTED.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT DEVELOPED PAIN, SWELLING AND TISSUE GRANULATION AT THE IMPLANT SITE. TREATMENT WITH ORAL ANTIBIOTICS AND INJECTABLE STEROIDS (DATE AND DURATION NOT REPORTED) WAS UNSUCCESSFUL, RESULTING IN THE DECISION TO DISCONTINUE USE OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59375 BA300 ABUTMENT 9MM COCHLEAR BAHA CONNECT SYSTEM LXB COCHLEAR BONE ANCHORED SYSTEM AB 92131 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention