BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIA400 IMPLANT 4MM W ABUTMENT 8MM

    MDR report key: 6536056 · Received May 2, 2017

    Report

    Report Number
    6000034-2017-00825
    Event Type
    Injury
    Date Received
    May 2, 2017
    Report Date
    May 15, 2017
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    PMA / PMN Number
    K121317
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON MAY 02, 2017, (B)(4).

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017, IN ORDER TO EXCISE SKIN AT THE IMPLANT SITE. THE IMPLANTED DEVICE REMAINS INSITU. THIS REPORT IS SUBMITTED JUNE 6, 2017.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED INFECTION AND PAIN AT THE ABUTMENT SITE. REVISION SURGERY IS PLANNED; HOWEVER, THIS HAS NOT OCCURRED AS OF THE DATE OF THIS REPORT, MAY 02, 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318218 BIA400 IMPLANT 4MM W ABUTMENT 8MM COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB 93330 132531

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention