BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3180007 · Received June 20, 2013

    Report

    Report Number
    6000034-2013-01063
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2013
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, ON (B)(6) 2013, THE PATIENT PRESENTED WITH INFLAMMATION WITHOUT INFECTION AND REPORTS OF PAIN AT IMPLANT SITE. ON (B)(6) 2013, THE SITE REPORTEDLY SHOWED IMPROVEMENT, HOWEVER, THE PATIENT REQUESTED THAT THE ABUTMENT BE REMOVED. THE SURGEON REMOVED THE ABUTMENT AND CLOSED THE SITE WITH SUTURES. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281321 FLANGE FIXTURE AND ABUTMENT LXB, PRODUCT CODE: LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention