BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 1081709 · Received July 25, 2008

    Report

    Report Number
    6000034-2008-00408
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    April 17, 2008
    Report Date
    June 24, 2008
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS, AB
    Product Code
    LXB
    PMA / PMN Number
    K984162
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS TYPE OF EVENT IS ADDRESSED IN THE DEVICE LABELING.

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, IN 2008, THE PT'S MOTHER REPORTED PAIN, SWELLING AND INFECTION AT THE IMPLANT SITE. REPORTEDLY, THE PROBLEMS HAD STARTED FOUR DAYS PRIOR BUT WHEN THE SITE WAS EXAMINED, THE EXTENT OF THE INFECTION INDICATED OTHERWISE. THE FLANGE FIXTURE WITH ABUTMENT CAME OUT DURING THE EXAMINATION. THERE WERE NO PREVIOUS REPORTS OF PAIN OR PROBLEMS PRIOR TO THE LOSS OF THE FIXTURE. INFO ON REPLACEMENT OF THE FIXTURE HAD NOT BEEN REPORTED AT THE TIME OF THIS REPORT, 07/24/08.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLANGE FIXTURE AND ABUTMENT LXB COCHLEAR BONE ANCHORED SOLUTIONS, AB 90434 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention