BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 5750293 · Received June 26, 2016

    Report

    Report Number
    6000034-2016-01274
    Event Type
    Injury
    Date Received
    June 26, 2016
    Report Date
    June 8, 2016
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    PMA / PMN Number
    K121317
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    THE CORRECT 510(K) NUMBER IS K121317, NOT K955713 AS PREVIOUSLY REPORTED. THE CORRECT IMPLANTED DATE IS (B)(6) 2016, NOT 02/08/2016 AS PREVIOUSLY REPORTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CLINIC, THE PATIENT DEVELOPED SWELLING AROUND THE ABUTMENT SITE AND WAS TREATED WITH THE ANTIBIOTICS (DATE AND DURATION NOT REPORTED). IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT DEVELOPED AN INFECTION AT THE IMPLANT SITE AND WAS SUBSEQUENTLY TREATED WITH ORAL ANTIBIOTICS (DATE AND DURATION NOT REPORTED). THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404483 FLANGE FIXTURE AND ABUTMENT MAH MAH COCHLEAR BONE ANCHORED SOLUTIONS AB BIA400 17599

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention