BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIA400 IMPLANT 4MM

    MDR report key: 7204801 · Received January 18, 2018

    Report

    Report Number
    6000034-2018-00146
    Event Type
    Injury
    Date Received
    January 18, 2018
    Report Date
    February 8, 2018
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    UDI-DI
    09321502033459
    PMA / PMN Number
    K121317
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: THE PRODUCT DETAIL REPORTED ON THE INITIAL REPORT ARE NOT CORRECT. THE DETAILS OF THE IMPLANT FIXTURE ARE CURRENTLY UNKNOWN. SHOULD THE DEVICE DETAILS BECOME AVAILABLE, A SUPPLEMENTARY REPORT SHALL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON JANUARY 19, 2018, BY COCHLEAR LTD. ON BEHALF OF COCHLEAR AMERICAS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN AND SWELLING AT THE ABUTMENT SITE IN (B)(6) 2017 AND SUBSEQUENTLY WAS TREATED WITH ANTIBIOTICS. IN (B)(6) 2017, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS. RE-IMPLANTATION IS PLANNED; HOWEVER IT IS YET TO OCCUR AS OF THE DATE OF THIS REPORT, JANUARY 19, 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46911 BIA400 IMPLANT 4MM COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB 93337 157913 09321502033459

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention