BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3090636 · Received May 2, 2013

    Report

    Report Number
    6000034-2013-00824
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 23, 2013
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K984162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT WAS ADMITTED TO THE HOSPITAL SUBSEQUENT TO A HEAD INJURY AT THE IMPLANT SITE. THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO REMOVE EXCESS SKIN OVERGROWTH, DURING WHICH THE PATIENT WAS INJECTED WITH KENALOG AND A LOCAL ANESTHETIC WITH EPINEPHRINE. A LONGER ABUTMENT WAS PLACED DURING THE PROCEDURE. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192466 FLANGE FIXTURE AND ABUTMENT LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 92135

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Hospitalization| R