BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIA300 IMPLANT 4MM W ABUTMENT 6MM

    MDR report key: 13022647 · Received December 16, 2021

    Report

    Report Number
    6000034-2021-03760
    Event Type
    Injury
    Date Received
    December 16, 2021
    Date of Event
    September 13, 2021
    Report Date
    November 29, 2021
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K100360
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO REPORTED INFECTION. THIS REPORT IS SUBMITTED ON DEC 17, 2021.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON DEC 17, 2021.

    Description of Event or Problem · 0

    PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION (TREATMENT UNKNOWN) AT THE ABUTMENT SITE. THE CONNECT DEVICE WAS CONVERTED TO AN OSIA DEVICE ON (B)(6) 2021 I.E., THE ABUTMENT WAS REMOVED AND THE OSIA WAS PLACED ON THE EXISTING IMPLANT. FURTHER INFORMATION IS BEING SOUGHT FROM THE CLINIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1918113 BIA300 IMPLANT 4MM W ABUTMENT 6MM COCHLEAR BAHA CONNECT SYSTEM LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 92127

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Female Required Intervention