BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3233966 · Received July 18, 2013

    Report

    Report Number
    6000034-2013-01325
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    July 9, 2013
    Report Date
    December 12, 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 92126, NOT 92127 AS PREVIOUSLY REPORTED. THIS REPORT IS FILED ON APRIL 25, 2014. IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    (B)(4): IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT DEVELOPED SKIN OVERGROWTH ON THE ABUTMENT AND SUBSEQUENTLY UNDERWENT A SURGICAL PROCEDURE UNDER GENREAL ANESTHESIA ON (B)(6), 2013, TO EXCISE THE EXCESS SKIN. A LONGER ABUTMENT WAS PLACED DURING THIS PROCEDURE. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336072 FLANGE FIXTURE AND ABUTMENT PRODUCT CODE: LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 92127

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Life Threatening| R