BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIA400 IMPLANT 4MM W ABUTMENT 14MM

    MDR report key: 9748500 · Received February 24, 2020

    Report

    Report Number
    6000034-2020-00498
    Event Type
    Injury
    Date Received
    February 24, 2020
    Date of Event
    January 24, 2020
    Report Date
    February 3, 2020
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON FEBRUARY 25, 2020.

    Description of Event or Problem · 1

    PER THE CLINIC, THERE WAS A SOFT TISSUE REVISION DURING AN ABUTMENT REMOVAL (REASON FOR THE REVISION IS UNKNOWN). A COVER SCREW WAS PLACED ON THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209322 BIA400 IMPLANT 4MM W ABUTMENT 14MM COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB 93338 COH1254094

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention