BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 2923980 · Received January 22, 2013

    Report

    Report Number
    6000034-2013-00140
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    December 28, 2012
    Report Date
    January 9, 2013
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN OVERGROWTH ON THE ABUTMENT. THE PATIENT UNDERWENT REVISION SURGERY TO EXCISE THE EXCESS SKIN ON (B)(6) 2012. THE IMPLANTED DEVICE REMAINS. IT WAS ALSO REPORTED THAT THE ABUTMENT WAS EXCHANGED FOR A LONGER MODEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29251 FLANGE FIXTURE AND ABUTMENT LXB, PRODUCT CODE: LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention