BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3081871 · Received April 29, 2013

    Report

    Report Number
    6000034-2013-00727
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    April 16, 2013
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT DEVELOPED AN ABSCESS AROUND THE IMPLANT SITE. THE PATIENT UNDERWENT A SURGICAL PROCEDURE (DATE NOT REPORTED), TO EXCISE INFECTED TISSUE AND REPLACE THE ABUTMENT WITH A LONGER MODEL. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185250 FLANGE FIXTURE AND ABUTMENT LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB N/A 95362

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention