BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIA400 IMPLANT 4MM W ABUTMENT 8MM

    MDR report key: 7189874 · Received January 15, 2018

    Report

    Report Number
    6000034-2018-00065
    Event Type
    Injury
    Date Received
    January 15, 2018
    Report Date
    January 15, 2018
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    UDI-DI
    09321502022705
    PMA / PMN Number
    K121317
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT'S DEVICE WAS EXPLANTED (DATE NOT REPORTED).

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON JANUARY 15, 2018. REGISTRATION NUMBER (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION IN (B)(6) 2017. THE IMPLANTED DEVICE REMAINS. REVISION SURGERY IS PLANNED; HOWEVER IS YET TO OCCUR AS OF THE DATE OF THIS REPORT JANUARY 15, 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35141 BIA400 IMPLANT 4MM W ABUTMENT 8MM COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB 93330 COH824568 09321502022705

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention