BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIA400 IMPLANT 4MM W ABUTMENT 8MM

    MDR report key: 9339327 · Received November 18, 2019

    Report

    Report Number
    6000034-2019-02422
    Event Type
    Injury
    Date Received
    November 18, 2019
    Date of Event
    August 1, 2019
    Report Date
    October 25, 2019
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    PMA / PMN Number
    K121317
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON NOVEMBER 19, 2019.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION OF THE IMPLANT (CAUSE UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131698 BIA400 IMPLANT 4MM W ABUTMENT 8MM COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB 93330

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention