BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPOSE® TONGUE AND HYOID SUSPENSION KIT

    MDR report key: 4252018 · Received November 14, 2014

    Report

    Report Number
    1045254-2014-00293
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 20, 2014
    Manufacturer
    MEDTRONIC XOMED, INC
    Product Code
    LRK
    PMA / PMN Number
    K981677
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). THE PRODUCT ANALYSIS CANNOT BE COMPLETED; THE DEVICE WILL NOT BE RETURNED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED, ¿REGRET TO SAY THAT I HAVE A PROBLEM WITH THE LAST AIR VANCE PATIENT. BASICALLY, I PLACED THE ANCHORS TOO HIGH ON THE MANDIBLE. ONE OF THE HYOID SUTURES, THE ONE ON THE RIGHT, HAS BECOME EXPOSED INTRAORALLY. THE SYMPHYSEAL ANCHOR WAS TOO HIGH ALSO AND THE TIP OF THE ANCHOR WAS EXPOSED IN THE MOUTH AND HAD TO BE REDUCED. I ALREADY DID THIS. I¿M DISAPPOINTED IN THIS TECHNICAL MISTAKE. IN THE FUTURE I THINK IT MAY BE BENEFICIAL TO CONFIRM TO LOCATION WITH AN ENDOSCOPE PRIOR TO SECURING THE ANCHORS RATHER THAN DOING IT BLINDLY. SO I CORRECT THIS I THINK I¿M GOING TO HAVE TO REMOVE THE HYOID SUTURE ON THE RIGHT SIDE WHICH MEANS WE¿LL LOSE THE HYOID SUSPENSION. SO MY THOUGHT IS SIMPLY TO REPEAT THE HYOID SUSPENSION PART AGAIN.¿ THE PATIENT HAD DEVELOPED A FISTULA AND INFECTION AT THE INCISION SITE, AND RETURNED TO SURGERY TO HAVE THE SUTURES REMOVED AND FISTULA TREATED. THE DOCTOR CONFIRMED THAT HE DID NOT BELIEVE THERE WAS ANYTHING WRONG WITH THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737553 REPOSE® TONGUE AND HYOID SUSPENSION KIT DEVICE, ANTI-SNORING LRK MEDTRONIC XOMED, INC 76353200

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention