BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 1792279 · Received August 10, 2010

    Report

    Report Number
    6000034-2010-00532
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    June 30, 2010
    Report Date
    October 12, 2010
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS
    Product Code
    LXB
    PMA / PMN Number
    K955713
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, BOTH TROCARS WERE LEAKING AND LOSING PNEUMO. OTHER TROCARS WERE USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF OSSEOINTEGRATION RESULTING IN FIXTURE LOSS. IT IS UNKNOWN WHETHER THERE ARE PLANS TO REIMPLANT THE PATIENT AS OF THE DATE OF THIS REPORT, AUGUST 10, 2010.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention