BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BI300 IMPLANT 4 MM

    MDR report key: 13146236 · Received January 3, 2022

    Report

    Report Number
    6000034-2022-00042
    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
    PMA / PMN Number
    K100360
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON JANUARY, 2022.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION : PER THE CLINIC, THE PATIENT WAS PLACED UNDER GENERAL ANAESTHESIA ON (B)(6) 2021 DURING THE EXPLANT PROCEDURE. THE REPORTED ADVERSE EVENT IS ASSOCIATED WITH A RETURNED DEVICE; HOWEVER, THE PROVIDED CLINICAL INFORMATION WAS REVIEWED BY THE MANUFACTURER AND NO SPECIFIC DEVICE ANALYSIS IS DEEMED NECESSARY AT THIS TIME. PREVIOUS PRODUCT EXAMINATIONS HAVE NOT SHOWED ANY RELATIONSHIP BETWEEN A PRODUCT GEOMETRICAL DEVIATION AND THE REPORTED CLINICAL COMPLICATION. ADDITIONALLY, THERE ARE NO INDICATIONS THAT A PRODUCT FAILURE HAS CONTRIBUTED TO THE REPORTED ISSUE. ADVERSE SKIN REACTIONS AROUND THE BAHA ABUTMENT, RANGING FROM SLIGHT REDNESS TO INFECTED TISSUE, ARE COMMON COMPLICATIONS WITH BAHA IMPLANTS, AND CAN OCCUR AT ANY TIME FOLLOWING IMPLANTATION. THE REPORT FREQUENCY FOR THESE COMPLICATIONS IS BEING MONITORED UNDER CBAS COMPLAINT AND MEDICAL DEVICE REPORTING DATA MONITORING PLAN AND THE STATUS IS UPDATED ON A MONTHLY BASIS. THIS EVENT IS ADDED TO THIS MONITORING. THIS REPORT IS SUBMITTED ON MARCH 28, 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 OCTOBER 7, 2021. IT IS UNKNOWN IF THERE ARE PLANS TO RE-IMPLANT THE PATIENT WITH ANOTHER DEVICE. FURTHER INFORMATION IS BEING SOUGHT FROM THE CLINIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1107213 BI300 IMPLANT 4 MM COCHLEAR BAHA CONNECT SYSTEM LBX COCHLEAR BONE ANCHORED SOLUTIONS AB 92129 COH1131204 09321502019545
    573660 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