BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIA400 IMPLANT 4MM W ABUTMENT 14MM

    MDR report key: 9748499 · Received February 24, 2020

    Report

    Report Number
    6000034-2020-00497
    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
    PMA / PMN Number
    K121317
    Report Source
    Manufacturer 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
    209321 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