BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTEMENT

    MDR report key: 1060897 · Received June 13, 2008

    Report

    Report Number
    6000034-2008-00327
    Event Type
    Injury
    Date Received
    June 13, 2008
    Report Date
    June 16, 2008
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS, AB,
    Product Code
    LXB
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LABELING: THE TYPE OF EVENT IS ADDRESSED IN THE DEVICE LABELING.

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, THE PT UNDERWENT A TISSUE REDUCTION SURGERY TO REMOVE EXCESS SKIN GROWING OVER THE ABUTMENT. THE PT HAS HAD THE SITE CLEANED AND CUT BACK NUMEROUS TIMES. THERE WERE NO COMPLICATIONS DURING THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLANGE FIXTURE AND ABUTEMENT BONE-ANCHORED IMPLANT LXB COCHLEAR BONE ANCHORED SOLUTIONS, AB, 90480 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention