BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIA400 IMPLANT 4MM W ABUTMENT 10MM

    MDR report key: 6927940 · Received October 9, 2017

    Report

    Report Number
    6000034-2017-01832
    Event Type
    Injury
    Date Received
    October 9, 2017
    Report Date
    September 25, 2017
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DETAILS UNAVAILABLE AT THE TIME OF THIS REPORT, THIS REPORT IS SUBMITTED ON OCTOBER 09, 2017. (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED INFLAMMATION AND INFECTION AT ABUTMENT SITE AND WAS SUBSEQUENTLY TREATED WITH ANTIBIOTICS (TYPE AND DATE NOT REPORTED) AND WOUND CARE. THERE ARE PLANS TO REMOVE THE ABUTMENT; HOWEVER THIS HAS NOT OCCURRED AS OF THE DATE OF THIS REPORT OCTOBER 09, 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709636 BIA400 IMPLANT 4MM W ABUTMENT 10MM COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB 93331 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention