BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLANGE FIXTURE AND ABUTMENT

    MDR report key: 1173450 · Received September 23, 2008

    Report

    Report Number
    6000034-2008-00555
    Event Type
    Injury
    Date Received
    September 23, 2008
    Date of Event
    August 28, 2008
    Report Date
    September 4, 2008
    Manufacturer
    COCHLEAR BONE ANCHORED SOLUTIONS, AB
    Product Code
    LXB
    PMA / PMN Number
    K984162
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT FILED, SEPT 23, 2008.

    Description of Event or Problem · 1

    PER THE SURGEON, THE PT WAS IMPLANTED WITH A PRIMARY AND SLEEPER FIXTURE. THE PT USED THE BAHA SYSTEM FOR APPROX FIVE YEARS, THEN IN 2007, THE PT REPORTED THE BAHA DEVICE "SOUNDED/FELT FUNNY" AND WOULD NOT USE IT. A CT SCAN DONE IN 2008 SHOWED THE SLEEPER FIXTURE "APPEARED TO BE MORE DEEPLY SAT, INTRA-CRANIALLY" THAN IT HAD BEEN FOLLOWING SURGERY. THE PT'S SLEEPER FIXTURE WAS EXPLANTED FOUR MONTHS LATER, DRILLING OUT THE AREA NECESSARY TO REMOVE THE FIXTURE AND COVER SCREW. A "SPLIT CALVARIAN" WAS USED TO COVER/PATCH THE BONEY AREA. SHORTLY AFTER, THE PT WAS RE-FIT WITH THE SOUND PROCESSOR ON HIS PRIMARY DEVICE. THE PT REPORTED EVERYTHING SOUNDED "GREAT" ONCE AGAIN. THE EXPLANTED FIXTURE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLANGE FIXTURE AND ABUTMENT LXB COCHLEAR BONE ANCHORED SOLUTIONS, AB 90430 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention