BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRVANCE BONE SCREW (REPOSE) SYSTEM

    MDR report key: 3027689 · Received March 29, 2013

    Report

    Report Number
    1045254-2013-00311
    Event Type
    Injury
    Date Received
    March 29, 2013
    Report Date
    March 4, 2013
    Manufacturer
    MEDTRONIC XOMED, INC
    Product Code
    LRK
    PMA / PMN Number
    K981677
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. THE OTHER SCREW IMPLANTED - PRODUCT # 76310200M, LOT # 72008900. IT IS UNKNOWN WHICH SCREW WAS NOT ATTACHED TO THE MANDIBLE DURING THE X-RAY. (B)(4). THE DEVICE WAS NOT RETURNED AND THEREFORE NO EVALUATION COULD BE PERFORMED. METHOD: THE DEVICE WAS NOT RETURNED AND THEREFORE NO EVALUATION COULD BE PERFORMED.

    Additional Manufacturer Narrative · 1

    PMA 510K # K981677 WAS LEFT OFF THE INITAL MDR.

    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 TWO SCREWS WERE IMPLANTED ON (B)(6) 2013. THE DOCTOR NOTICED ONE OF THE SCREWS WAS NOT ATTACHED TO THE MANDIBLE AT FOLLOW UP APPOINTMENT WITH THE PATIENT AFTER GETTING AN X-RAY OF THE PATIENT, AND THE PATIENT WAS COMPLAINING OF NUMBNESS IN HIS LIP AND JAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130741 AIRVANCE BONE SCREW (REPOSE) SYSTEM DEVICE, ANTI-SNORING LRK MEDTRONIC XOMED, INC 76353200M 0206373440

    Patients

    Seq Age Sex Outcome Treatment
    1 Other