BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3864442 · Received June 10, 2014

    Report

    Report Number
    6000034-2014-00805
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 29, 2014
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K984162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT WAS TAKEN TO THE OPERATING ROOM ON (B)(6) 2014 AND ADMINISTERED GENERAL ANESTHESIA TO FACILITATE WITH THE PLACEMENT OF AN ABUTMENT. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338911 FLANGE FIXTURE AND ABUTMENT LXB, PRODUCT CODE LXB COCHLEAR BONE ANCHORED SOLUTIONS AB

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention