BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COCHLEAR BAHA CONNECT SYSTEM, PRODUCT CODE: LXB

    MDR report key: 10286792 · Received July 16, 2020

    Report

    Report Number
    6000034-2020-01827
    Event Type
    Injury
    Date Received
    July 16, 2020
    Report Date
    July 31, 2020
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT UNDERWENT SUCCESSFUL CONVERSION FROM THE BAHA CONNECT TO THE OSIA UNDER A GENERAL ANAESTHETIC ON (B)(6) 2020. THIS REPORT IS SUBMITTED ON AUGUST 21, 2020.

    Description of Event or Problem · 0

    THE PATIENT UNDERWENT SUCCESSFUL CONVERSION FROM THE BAHA CONNECT TO THE OSIA UNDER A GENERAL ANAESTHETIC ON (B)(6) 2020.

    Description of Event or Problem · 1

    PER THE CLINIC, IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AND SKIN OVERGROWTH AT THE ABUTMENT SITE. SUBSEQUENTLY, THE PATIENT WAS TREATED WITH TOPICAL ANTIBIOTICS. REVISION SURGERY IS PLANNED; HOWEVER, YET TO OCCUR AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745371 COCHLEAR BAHA CONNECT SYSTEM, PRODUCT CODE: LXB COCHLEAR BAHA CONNECT SYSTEM LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 92133 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention