BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE ST 4MM W. BAHA ABUTMENT

    MDR report key: 9956004 · Received April 13, 2020

    Report

    Report Number
    6000034-2020-01050
    Event Type
    Injury
    Date Received
    April 13, 2020
    Report Date
    May 6, 2020
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PER THE CLINIC, THE INFECTION WAS SUCCESSFULLY TREATED WITH ANTIBIOTICS (IV, ORAL AND TOPICAL). THIS REPORT IS SUBMITTED ON MAY 25 2020.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS SUBMITTED ON 14 APRIL 2020.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S ABUTMENT WAS REMOVED DUE TO INFECTION AT IMPLANT SITE (DATE NOT REPORTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419165 FLANGE FIXTURE ST 4MM W. BAHA ABUTMENT COCHLEAR BAHA CONNECT SYSTEM LXB COCHLEAR BONE ANCHORED SOLUTIONS AB 90434 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention