BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 4222297 · Received November 3, 2014

    Report

    Report Number
    6000034-2014-01599
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    October 14, 2014
    Report Date
    October 14, 2014
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K100360
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FIXTURE REMAINS INSITU.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AROUND THE IMPLANT SITE. THE ABUTMENT HAS BEEN REMOVED ON (B)(6) 2014. THE FIXTURE REMAINS INSITU. NO FURTHER INFORMATION WAS MADE AVAILABLE AS OF THE DATE OF THIS REPORT, NOVEMBER 4, 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703239 FLANGE FIXTURE AND ABUTMENT LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention