BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 2062671 · Received April 19, 2011

    Report

    Report Number
    6000034-2011-00271
    Event Type
    Injury
    Date Received
    April 19, 2011
    Report Date
    December 1, 2010
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS AB
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT AVAILABLE FOR ANALYSIS.

    Description of Event or Problem · 1

    MANUFACTURER BECAME AWARE UPON RECEIPT OF A COPY OF A JOURNAL ARTICLE. THE CASE REPORTED WAS THAT OF A PATIENT WHO FELL, SUSTAINING A TRAUMATIC IMPACT DIRECTLY OVER THE SITE OF THE FIXTURE/ABUTMENT. THE INCIDENT OCCURRED 2 YEARS POST IMPLANTATION. A "THIN BRITTLE SKULL" WAS ENCOUNTERED DURING INITIAL SURGERY, HOWEVER, FULL OSSEOINTEGRATION WAS REPORTED AND THE PATIENT WAS USING THE DEVICE PRIOR TO THE TRAUMA. THE PATIENT WAS TAKEN TO THE ER AFTER THE INJURY, AND A CT SCAN REVEALED A RIGHT PARIETAL SKULL FRACTURE AND AN EPIDURAL HEMATOMA. SURGICAL INTERVENTION WAS REQUIRED TO MANAGE THE FRACTURE AND HEMATOMA. THE FIXTURE WAS REMOVED DURING THE SURGERY. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention