BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STANDARD ABUTMENT 7MM

    MDR report key: 5730695 · Received June 16, 2016

    Report

    Report Number
    6000034-2016-01218
    Event Type
    Injury
    Date Received
    June 16, 2016
    Date of Event
    June 3, 2016
    Report Date
    September 26, 2016
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    FZE
    PMA / PMN Number
    K945154
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: THE CORRECT BRAND NAME IS: 'STANDARD ABUTMENT 7MM', NOT 'FLANGE FIXTURE AND ABUTMENT' AS PREVIOUSLY REPORTED. THE CORRECT COMMON DEVICE NAME IS 'COCHLEAR BAHA VISTAFIX SYSTEM', NOT 'LXB' AS PREVIOUSLY REPORTED. THE CORRECT PRODUCT CODE IS: FZE, NOT 'LXB' AS PREVIOUSLY REPORTED. THE CORRECT CATALOG # IS 90774, NOT 90776 AS PREVIOUSLY REPORTED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED JUNE 16, 2016. THE IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED SKIN OVERGROWTH AT THE ABUTMENT SITE. SUBSEQUENTLY, ON (B)(6) 2016, THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO EXCISE THE EXCESS SKIN. DURING THE SAME PROCEDURE, THE SITE WAS TREATED WITH SILVER NITRATE. ON (B)(6) 2016, ADDITIONAL SKIN WAS EXCISED. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384580 STANDARD ABUTMENT 7MM COCHLEAR BAHA VISTAFIX SYSTEM FZE COCHLEAR BONE ANCHORED SOLUTIONS AB 90774 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention