BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIA400 IMPLANT 4MM W ABUTMENT 10MM

    MDR report key: 7202913 · Received January 18, 2018

    Report

    Report Number
    6000034-2018-00097
    Event Type
    Injury
    Date Received
    January 18, 2018
    Report Date
    December 27, 2017
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    UDI-DI
    09321502022712
    PMA / PMN Number
    K121317
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED JANUARY 18, 2018, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED RECURRENT INFECTIONS AT THE ABUTMENT SITE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT, JANUARY 18, 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47792 BIA400 IMPLANT 4MM W ABUTMENT 10MM COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB 93331 135354 09321502022712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention