BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE ST 4MM W. BAHA ABUTMENT

    MDR report key: 6967892 · Received October 22, 2017

    Report

    Report Number
    6000034-2017-01955
    Event Type
    Injury
    Date Received
    October 22, 2017
    Report Date
    October 12, 2017
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    UDI-DI
    09321502014359
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON OCTOBER 23, 2017, (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS. THERE ARE PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE; HOWEVER, THIS HAS NOT OCCURRED AS OF THE DATE OF THIS REPORT, OCTOBER 23, 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747295 FLANGE FIXTURE ST 4MM W. BAHA ABUTMENT COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB 90434 604979 09321502014359

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention