BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIA400 IMPLANT 4MM W ABUTMENT 10MM

    MDR report key: 5129278 · Received October 5, 2015

    Report

    Report Number
    6000034-2015-01978
    Event Type
    Injury
    Date Received
    October 5, 2015
    Date of Event
    September 9, 2015
    Report Date
    February 1, 2016
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    PMA / PMN Number
    K121317
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, THE PATIENT WAS ADMINISTERED WITH INJECTABLE STEROIDS DUE TO SWELLING AT THE IMPLANT SITE. THIS REPORT IS FILED NOVEMBER 17TH, 2015. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    CORRECTION: THE CORRECT BRAND NAME IS: BIA400 IMPLANT 4MM W ABUTMENT 10MM NOT FLANGE FIXTURE AND ABUTMENT AS PREVIOUSLY REPORTED. THE CORRECT COMMON DEVICE NAME IS COCHLEAR BAHA CONNECT SYSTEM NOT LXB, PRODUCT CODE: LXB AS PREVIOUSLY REPORTED. THE CORRECT PRODUCT CODE IS: MAH, NOT LXB AS PREVIOUSLY REPORTED. THE CORRECT PMA/510(K) NUMBER IS K121317,K100360 AS PREVIOUSLY REPORTED. (B)(4)

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT WAS TREATED WITH ANTIBITIOCIS DUE TO RECURRING SKIN PROBLEMS AT THE ABUTMENT SITE; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE PATIENT UNDWERNT REVISION SURGERY (SPECIFIC DATE NOT REPORTED) TO REPLACE THE ABUTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657794 BIA400 IMPLANT 4MM W ABUTMENT 10MM COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB 93331

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention