BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIA300 IMPLANT 4MM W ABUTMENT 9MM

    MDR report key: 12215586 · Received July 22, 2021

    Report

    Report Number
    6000034-2021-02301
    Event Type
    Injury
    Date Received
    July 22, 2021
    Report Date
    July 14, 2021
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K100360
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON JULY 23, 2021.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS. REIMPLANTATION IS PLANNED BUT HAS NOT YET TAKEN PLACE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1105451 BIA300 IMPLANT 4MM W ABUTMENT 9MM COCHLEAR BAHA CONNECT SYSTEM LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 92346 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention