BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 6032709 · Received October 16, 2016

    Report

    Report Number
    6000034-2016-01961
    Event Type
    Injury
    Date Received
    October 16, 2016
    Report Date
    September 20, 2016
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    PMA / PMN Number
    K121317
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL IMPLANTATION AND DEVICE DETAILS UNAVAILABLE AT THE TIME OF THIS REPORT, THIS REPORT IS FILED ON OCTOBER 17, 2016. REGISTRATION NUMBER 3009092818 EXEMPTION NUMBER E2016011. H3 OTHER TEXT : IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION (DATE NOT REPORTED), RE-IMPLANTATION IS PLANNED BUT HAD NOT TAKEN PLACE AT THE TIME OF THIS REPORT, OCTOBER 17, 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684049 FLANGE FIXTURE AND ABUTMENT MAH MAH COCHLEAR BONE ANCHORED SOLUTIONS AB N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention