BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIA400 IMPLANT 4MM W ABUTMENT 12MM

    MDR report key: 5364891 · Received January 13, 2016

    Report

    Report Number
    6000034-2016-00055
    Event Type
    Injury
    Date Received
    January 13, 2016
    Date of Event
    December 17, 2015
    Report Date
    April 7, 2016
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY UNAVAILABLE.

    Additional Manufacturer Narrative · 1

    CORRECTION: THE CORRECT BRAND NAME IS: BIA400 IMPLANT 4MM W ABUTMENT 12MM, NOT BAHA FLANGE AND ABUTMENT AS PREVIOUSLY REPORTED. THE CORRECT COMMON DEVICE NAME IS COCHLEAR BAHA CONNECT SYSTEM, NOT LXB: PRODUCT CODE, PRODUCT CODE: LXB AS PREVIOUSLY REPORTED. THE CORRECT PRODUCT CODE IS: MAH NOT LXB AS PREVIOUSLY REPORTED. THE CORRECT 510(K) NUMBER IS K121317 NOT K955713. THIS REPORT IS FILED ON JULY 05, 2017 (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION ON (B)(6) 2015 RESULTING IN FIXTURE LOSS. THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR ANALYSIS AS OF THE DATE OF THIS REPORT, JANUARY 13, 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21643 BIA400 IMPLANT 4MM W ABUTMENT 12MM COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB 93332 126829

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention