BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIA400 IMPLANT 4MM WITH ABUTMENT 12MM

    MDR report key: 5701812 · Received June 6, 2016

    Report

    Report Number
    6000034-2016-01133
    Event Type
    Injury
    Date Received
    June 6, 2016
    Report Date
    August 30, 2016
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    PMA / PMN Number
    K121317
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PER THE CLINIC, IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS EXPLANTED ON (B)(6) 2016. REGISTRATION NUMBER 3009092818 AND EXEMPTION NUMBER E2016011.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED, JUNE 6, 2016. THE IMPLANTED DEVICE REMAINS IN-SITU.

    Additional Manufacturer Narrative · 1

    CORRECTION: THE CORRECT BRAND NAME IS: 'BIA400 IMPLANT 4MM W ABUTMENT 12MM', NOT 'FLANGE FIXTURE AND ABUTMENT' AS PREVIOUSLY REPORTED. THE CORRECT COMMON DEVICE NAME IS COCHLEAR BAHA CONNECT SYSTEM, NOT 'LXB' AS PREVIOUSLY REPORTED. THE CORRECT 510(K) NUMBER IS K121317, NOT 'K955713' AS PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION (DATE NOT REPORTED) RESULTING IN LOOSE FIXTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356067 BIA400 IMPLANT 4MM WITH ABUTMENT 12MM COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB 93332 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention