BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 2942613 · Received February 4, 2013

    Report

    Report Number
    6000034-2013-00187
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 15, 2013
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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 DEVELOPED AN INFECTION AT THE IMPLANT SITE. THE PATIENT UNDERWENT A PROCEDURE ON (B)(6) 2013, TO HAVE THE ABSCESS DRAINED. IT WAS ALSO REPORTED THAT THE PATIENT IS BEING TREATED WITH A SEVEN DAY COURSE OF BACTRIM DS, BEGINNING ON (B)(6) 2013. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45907 FLANGE FIXTURE AND ABUTMENT LXB, PRODUCT CODE: LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 126829

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention