BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI300 IMPLANT 4 MM

    MDR report key: 13146237 · Received January 3, 2022

    Report

    Report Number
    6000034-2022-00043
    Event Type
    Injury
    Date Received
    January 3, 2022
    Date of Event
    October 7, 2021
    Report Date
    March 9, 2022
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LBX
    UDI-DI
    09321502019545
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON JANUARY, 2022.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION (TREATMENT UNKNOWN) AT THE ABUTMENT SITE. THE DEVICE WAS EXPLANTED (B)(6) 2021. IT IS UNKNOWN IF THERE ARE PLANS TO RE-IMPLANT THE PATIENT WITH ANOTHER DEVICE. FURTHER INFORMATION IS BEING SOUGHT FROM THE CLINIC.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: PER THE CLINIC, THE PATIENT WAS PLACED UNDER GENERAL ANAESTHESIA ON (B)(6) 2021 DURING THE EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24410 BI300 IMPLANT 4 MM COCHLEAR BAHA CONNECT SYSTEM LBX COCHLEAR BONE ANCHORED SOLUTIONS AB 92129 COH1131204 09321502019545
    643574 BI300 IMPLANT 4 MM COCHLEAR BAHA CONNECT SYSTEM LBX COCHLEAR BONE ANCHORED SOLUTIONS AB 92129 COH1131204 09321502019545

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Female Required Intervention