BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 1081810 · Received July 25, 2008

    Report

    Report Number
    6000034-2008-00414
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    July 1, 2008
    Report Date
    June 26, 2008
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS, AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, THE PATIENT REPORTED AUDIBLE FEEDBACK FROM THE SOUND PROCESSOR WHEN USING THE DEVICE. EXAMINATION OF THE IMPLANT SITE SHOWED MILD INFECTION AROUND THE ABUTMENT, SOME SKIN REGROWTH AND AN UNUSUAL PLACEMENT OF THE FIXTURE WITH RESPECT TO THE CONTOURS OF THE PATIENT'S HEAD. THE PROCESSOR WAS TOUCHING THE SKIN DUE TO THE UNUSUAL FIXTURE PLACEMENT, WHICH CAUSED THE FEEDBACK. THE PATIENT UNDERWENT REVISION SURGERY TO PLACE A NEW ABUTMENT IN 2008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLANGE FIXTURE AND ABUTMENT LXB COCHLEAR BONE ANCHORED SOLUTIONS, AB 90305 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention