BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIA400 IMPLANT 4MM W ABUTMENT 6MM

    MDR report key: 6065971 · Received October 30, 2016

    Report

    Report Number
    6000034-2016-02088
    Event Type
    Injury
    Date Received
    October 30, 2016
    Report Date
    November 1, 2016
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    PMA / PMN Number
    K121317
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CLINIC, THE PATIENT WAS TREATED WITH ORAL AND TOPICAL ANTIBIOTICS (DATE NOT REPORTED) FOR THE INFECTION. THE IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE IMPLANT SITE. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NOT MADE AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716988 BIA400 IMPLANT 4MM W ABUTMENT 6MM COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB 93329 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention