BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIA400 IMPLANT 4MM W ABUTMENT 14MM

    MDR report key: 15757739 · Received November 9, 2022

    Report

    Report Number
    6000034-2022-03317
    Event Type
    Injury
    Date Received
    November 9, 2022
    Date of Event
    December 11, 2018
    Report Date
    October 16, 2022
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    MAH
    PMA / PMN Number
    K121317
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED ON NOVEMBER 09, 2022.

    Description of Event or Problem · 0

    PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2018, DUE INFECTION AT IMPLANT SITE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2282352 BIA400 IMPLANT 4MM W ABUTMENT 14MM COCHLEAR BAHA CONNECT SYSTEM MAH COCHLEAR BONE ANCHORED SOLUTIONS AB 93338 COH824571

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention