BEUDAMED
    FDA Adverse Event Summary report: N

    COCHLEAR¿ VISTAFIX® VXA300 ABUTMENT 7.5MM

    MDR report key: 6192193 · Received December 20, 2016

    Report

    Report Number
    6000034-2016-02515
    Date Received
    December 20, 2016
    Date of Event
    November 28, 2016
    Report Date
    November 30, 2016
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    FZE
    PMA / PMN Number
    K945154
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH ON THE ABUTMENT. SUBSEQUENTLY, THE PATIENT UNDERWENT REVISION SURGERY UNDER GENERAL ANESTHESIA TO EXCISE THE EXCESS SKIN AND FOR REMOVAL OF THE ABUTMENT ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840317 COCHLEAR¿ VISTAFIX® VXA300 ABUTMENT 7.5MM COCHLEAR BAHA CONNECT SYSTEM FZE COCHLEAR BONE ANCHORED SOLUTIONS AB 92997 155998

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention