BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIA400 IMPLANT 4MM W ABUTMENT 10MM

    MDR report key: 9838159 · Received March 16, 2020

    Report

    Report Number
    6000034-2020-00714
    Event Type
    Injury
    Date Received
    March 16, 2020
    Report Date
    February 19, 2020
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    UDI-DI
    09321502019545
    PMA / PMN Number
    K121317
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON MARCH 16, 2020.

    Description of Event or Problem · 1

    PER THE CLINIC, THERE WAS A LOSS OF IMPLANT OSSEOINTEGRATION SHORTLY AFTER THE INITIAL IMPLANT. THE PATIENT WAS NOT REIMPLANTED WITH A NEW DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297530 BIA400 IMPLANT 4MM W ABUTMENT 10MM COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB 93331 COH1311016 09321502019545

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention