BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3914168 · Received July 3, 2014

    Report

    Report Number
    6000034-2014-00932
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    March 26, 2010
    Report Date
    June 12, 2014
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH ON THE ABUTMENT. SUBSEQUENTLY, THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2010, TO EXCISE THE EXCESS SKIN. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391903 FLANGE FIXTURE AND ABUTMENT LXB: PRODUCT CODE LXB COCHLEAR BONE ANCHORED SOLUTIONS AB

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention