BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3091956 · Received May 3, 2013

    Report

    Report Number
    6000034-2013-00802
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 23, 2013
    Report Date
    September 18, 2013
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR ANALYSIS.THIS REPORT IS FILED NOVEMBER 29, 2013.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2013, TO REMOVE THE ABUTMENTS AND CLOSE THE IMPLANT SITE DUE TO CHRONIC INFECTIONS CAUSED BY A LACK OF HYGIENE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194337 FLANGE FIXTURE AND ABUTMENT LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 92130

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention