BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 5814632 · Received July 21, 2016

    Report

    Report Number
    6000034-2016-01346
    Event Type
    Injury
    Date Received
    July 21, 2016
    Report Date
    September 9, 2016
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K100360
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: THE CORRECT PATIENT IDENTIFIER IS (B)(6), NOT (B)(6) AS INITIALLY REPORTED. CORRECTION: THE CORRECT COMMON DEVICE NAME IS LXB, NOT MAH AS INITIALLY REPORTED CORRECTION: THE CORRECT CATALOG NUMBER IS 92130, NOT FCMB400 AS INITIALLY REPORTED. CORRECTION: THE CORRECT 510K NUMBER IS K100360, NOT K121317. (B)(4). IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON JULY 22, 2016, BY COCHLEAR LIMITED ON BEHALF OF (B)(4). IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED CHRONIC INFECTIONS AND SKIN OVERGROWTH AT THE IMPLANT SITE. REVISION SURGERY IS PLANNED; HOWEVER IT IS UNKNOWN WHETHER THIS HAS OCCURRED, AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465539 FLANGE FIXTURE AND ABUTMENT LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB BA300 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention