BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3141273 · Received June 3, 2013

    Report

    Report Number
    6000034-2013-00998
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    February 1, 2013
    Report Date
    December 13, 2013
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED DECEMBER 17, 2013.

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A SKIN FLAP INFECTION WITH PAIN AND LOOSENING OF ABUTMENT; HOWEVER, ATTEMPTS TO TIGHTEN THE ABUTMENT WERE UNSUCCESSFUL. THE PATIENT UNDERWENT REVISION SURGERY IN (B)(6) 2013 (SPECIFIC DATE NOT REPORTED) TO REMOVE EXCESS SKIN AROUND THE ABUTMENT SIDE. THE INFECTION AROUND THE ABUTMENT SIDE CONTINUED AND TREATMENT WITH ORAL ANTIBIOTICS IS ATTEMPTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT, (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244968 FLANGE FIXTURE AND ABUTMENT LXB, PRODUCT CODE: LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 89498

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention