BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRVANCE¿ THS SYSTEM - BONE SCREW WITH SUTURE

    MDR report key: 5255778 · Received November 30, 2015

    Report

    Report Number
    1045254-2015-00395
    Event Type
    Injury
    Date Received
    November 30, 2015
    Report Date
    November 6, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    LRK
    PMA / PMN Number
    K981677
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT DEVICES: BONE SCREW 76353200M AIRVANCE, 510K: K981677, LOT# 0207641129, MFR DATE: 2013-10-24, USE BEFORE 2015-10-24. (B)(4). THE PRODUCT HAS NOT BEEN RETURNED FOR ANALYSIS.

    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 THAT "THE PATIENT CAME TO [DR. (B)(6)] WITH COMPLAINTS. WHEN DR. (B)(6) OPENED THE AREA WHERE SCAR TISSUE HAD FORMED, THE PROLENE SUTURES WERE BROKEN AND IT SEEMED THE PATIENT NEVER WAS SUSPENDED FROM LATE IN 2013. "FURTHER INFORMATION FROM THE COMPLAINANT INCLUDES: "THE PATIENT PRESENTED WITH A LARGE 'GOLF BALL' SIZED PIECE OF SCAR TISSUE THAT HE SAID HIS ENT SURGEON WHO DID THE IMPLANTATION, SAID WAS JUST THE 'RISK ONE TAKES WITH ANY KIND OF SURGERY.' "AT THIS POINT, DR. (B)(6) THINKS IT WAS MORE THE PROCEDURE USED AND THE SURGEON NOT KNOWING HOW TO PROPERLY 'TAG' THE SUTURES OFF TO THE SIDES AS WELL AS HOW TO PROPERLY IMPLANT THE MANDIBULAR SCREWS BECAUSE OF THEIR INADEQUATE POSITIONING. DR. (B)(6) REMOVED THE SCAR TISSUE AND FOUND THE HYOID 90 DEGREES VERTICALLY AND BROKEN SUTURES BURIED IN SCAR TISSUE AS WELL AS THE SCREWS NOT EVEN ANCHORED WAY OUT OF POSITION. DR. (B)(6) LEFT THE 3 SCREWS IN THE PATIENT (2 FOR HYOID AND 1 FOR TONGUE SUSPENSION) AND PLACED TWO NEW SCREWS IN THE MANDIBLE (NOW 5 TOTAL), USING THE 2CM INCISION UNDER THE MANDIBLE SO HE COULD VISUALIZE THE MANDIBLE AND 'SEAT' THE SCREWS PROPERLY. THE PATIENT SEEMS TO BE DOING VERY WELL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784513 AIRVANCE¿ THS SYSTEM - BONE SCREW WITH SUTURE DEVICE, ANTI-SNORING LRK MEDTRONIC XOMED INC. 76310200M 0207529995

    Patients

    Seq Age Sex Outcome Treatment
    1 00030 YR Required Intervention