BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3924535 · Received July 10, 2014

    Report

    Report Number
    6000034-2014-00911
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 13, 2014
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K121317
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DEVICE NOT YET RECEIVED BY MANUFACTURER.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED AN INFECTION AROUND THE IMPLANT SITE. CLEANING OF THE SITE AND TREATMENT WITH TOPICAL CREAM (DURATION AND DOSAGE NOT REPORTED) WAS ATTEMPTED; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. FURTHER TREATMENT WITH ANTIBIOTICS (TYPE, DURATION AND DOSAGE NOT REPORTED) TEMPORARILY RESOLVED THE ISSUE, HOWEVER; INFLAMMATION AROUND THE IMPLANT SITE RECURRED. THE PATIENT UNDERWENT A PROCEDURE (DATE NOT REPORTED) TO EXCISE, CAUTERISE AND DEBRIDE THE SITE; HOWEVER THE ISSUE COULD NOT BE RESOLVED RESULTING IN THE DESISION TO REMOVE THE ABUTMENT (DATE NOT REPORTED). THE PATIENT WAS EQUIPPED WITH A NEW ABUTMENT (DATE NOT REPORTED) AND THE INFECTION HAS CLEARED. THE FIXTURE REMAINED INSITU AT ALL TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404437 FLANGE FIXTURE AND ABUTMENT LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention