BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRVANCE BONE SCREW (REPOSE)

    MDR report key: 2992699 · Received March 7, 2013

    Report

    Report Number
    1045254-2013-00226
    Event Type
    Injury
    Date Received
    March 7, 2013
    Report Date
    February 11, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    LRK
    PMA / PMN Number
    K981677
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS REPORT ARE THE RESULT OF INFORMATION NOT BEING PROVIDED BY INITIAL REPORTER. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). PRODUCT NOT RETURNED FOR ANALYSIS. ANALYSIS: THIS DEVICE WAS NOT RETURNED FOR EVALUATION. METHOD: NO TESTING METHODS PERFORMED. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AS REPORTED, DURING A POST-OP VISIT THAT TOOK PLACE 3-4 WEEKS AFTER THE HYOID SUSPENSION PROCEDURE (THE DATE OF THE PROCEDURE AND POST-OP ARE NOT KNOWN AT THIS TIME) THE PATIENT LET THE PHYSICIAN KNOW THAT AT SOME POINT HE HAD YAWNED AND FELT SOMETHING POP IN HIS JAW. THE PHYSICIAN THINKS THAT THE SUTURE MAY HAVE BROKEN OFF THE SCREW. ADDITIONAL INFORMATION RECEIVED AT A LATER DATE STATED THAT THE PATIENT EXPERIENCED PAIN WHEN THE INITIAL COMPLAINT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97151 AIRVANCE BONE SCREW (REPOSE) DEVICE, ANTI-SNORING LRK MEDTRONIC XOMED, INC. 76310200M NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1