BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 3943104 · Received July 18, 2014

    Report

    Report Number
    6000034-2014-01072
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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 BONE OVERGROWTH AND SOFT TISSUE PROBLEMS AROUND THE IMPLANT SITE. THE PATIENT UNDERWENT TWO SURGERIES AND A PETROSECTOMY (DATES NOT REPORTED); HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE ABUTMENT WAS REMOVED IN 2013 (SPECIFIC DATE NOT REPORTED) FOR 6 MONTHS AND THE PATIENT WAS EQUIPMENT WITH A LONGER ABUTMENT. PAIN AND SWELLING RECURRED AROUND THE IMPLANT SITE. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND STEROIDS (TYPE, DURATION AND DOSAGE NOT REPORTED); HOWEVER, THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS EXPLANTED IN (B)(6) 2014 (SPECIFIC DATE NOT REPORTED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421911 FLANGE FIXTURE AND ABUTMENT LXB LXB COCHLEAR BONE ANCHORED SOLUTIONS AB

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention