BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3260351 · Received August 1, 2013

    Report

    Report Number
    6000034-2013-01407
    Event Type
    Injury
    Date Received
    August 1, 2013
    Report Date
    August 26, 2013
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). CORRECTION: THE CORRECT CATALOG NUMBER IS 92130; NOT 90432 AS PREVIOUSLY REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4): IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6), 2013, TO MANAGE SKIN OVERGROWTH AROUND ABUTMENT SITE; DURING THIS PROCEDURE THE ABUTMENT WAS EXCHANGED. IT WAS ALSO REPORTED THAT THE PATIENT HAS UNDERGONE SEVEN PREVIOUS SURGERIES (DATES NOT REPORTED) TO MANAGE SKIN OVERGROWTH, SINCE INITIAL IMPLANTATION ON (B)(6), 2012. THE PATIENT HAS ALSO RECEIVED KENALOG INJECTIONS (DATES AND DOSAGES NOT REPORTED). THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359762 FLANGE FIXTURE AND ABUTMENT LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention