BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 5737417 · Received June 20, 2016

    Report

    Report Number
    6000034-2016-01232
    Event Type
    Injury
    Date Received
    June 20, 2016
    Report Date
    August 10, 2016
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    PMA / PMN Number
    K121317
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CORRECT PMA/510(K) IS, K121317; NOT K100360 AS PREVIOUSLY REPORTED. IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT DEVELOPED SKIN REACTIONS AT THE ABUTMENT SITE, AN INFECTION WAS SUSPECTED; SUBSEQUENTLY THE PATIENT WAS TREATED WITH TOPICAL AND ORAL ANTIBIOTICS (DATE NOT REPORTED). THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389953 FLANGE FIXTURE AND ABUTMENT MAH MAH COCHLEAR BONE ANCHORED SOLUTIONS AB BIA400 152280

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention