BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRVANCE BONE SCREW (REPOSE) SYSTEM

    MDR report key: 2940226 · Received February 2, 2013

    Report

    Report Number
    1045254-2013-00070
    Event Type
    Malfunction
    Date Received
    February 2, 2013
    Date of Event
    October 8, 2012
    Report Date
    January 8, 2013
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    LRK
    PMA / PMN Number
    K972023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULT: STRESS PROBLEM. ANALYSIS OF THE RETURNED COMPLAINT DEVICE DETERMINED THAT THE BONE SCREW WAS FRACTURED IN BOTH TENSION AND TORSIONAL SHEER DUE TO AN OVERLOAD CONDITION PRESENTED BY THE OPERATOR. THERE WAS NO INDICATION THE BONE SCREW WAS OUT OF SPECIFICATION.

    Description of Event or Problem · 1

    THIS EVENT WAS ORIGINALLY REPORTED TO MEDTRONIC AS A MISSING SCREW IN THE SCREW GUN. THE SURGEON REALIZED THE MISSING SCREW DURING THE PROCEDURE. THERE WAS NO PATIENT INJURY AND THE PATIENT'S CONDITION WAS REPORTED TO BE 'GOOD.' DEVICE ANALYSIS CONFIRMED ON (B)(6) 2013 THAT THE BONE SCREW WAS THERE, BUT WAS FRACTURED IN BOTH TENSIONAL AND TORSIONAL SHEER DUE TO AN OVERLOAD CONDITION PRESENTED BY THE OPERATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45687 AIRVANCE BONE SCREW (REPOSE) SYSTEM DEVICE, ANTI-SNORING LRK XOMED MFG JACKSONVILLE 76353200M 0205460289

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR