BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3852397 · Received June 5, 2014

    Report

    Report Number
    6000034-2014-00771
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 14, 2014
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED INFLAMMATION AT THE IMPLANT SITE RESULTING IN A DECISION TO EXPLANT THE DEVICE ON (B)(6) 2014. IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT, (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329360 FLANGE FIXTURE AND ABUTMENT LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 132685

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention