BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 1020672 · Received March 27, 2008

    Report

    Report Number
    6000034-2008-00140
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    March 1, 2007
    Report Date
    March 27, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT. LABELING: THE TYPE OF EVENT IS ADDRESSED IN THE DEVICE LABELING.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILLED RETROSPECTIVELY PER THE FDA'S REQUEST. THE PATIENT REPORTED INCREASED DIFFICULTY WEARING THE BAHA SOUND PROCESSOR DUE TO "SKIN OVERGROWTH" ON THE ABUTMENT. IN 2007, THE PATIENT UNDERWENT A TISSUE REDUCTION SURGERY. PER THE SURGEON'S REPORT, THE "ABUTMENT WAS DOING FINE AFTER A LITTLE SKIN REVISION" AND THERE ARE NO FURTHER PROBLEMS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention