BEUDAMED
    FDA Adverse Event Other Summary report: N

    PARALLAX CLEARVIEW ACCESS NEEDLE

    MDR report key: 2116819 · Received June 1, 2011

    Report

    Report Number
    2951580-2011-00075
    Event Type
    Other
    Date Received
    June 1, 2011
    Date of Event
    September 2, 2010
    Report Date
    June 1, 2011
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    KDD
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE WAS NOT RETURNED FOR INVESTIGATION, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. A LOT HISTORY REVIEW WAS PERFORMED. NO ABNORMALITIES WERE FOUND IN THE LOT HISTORY REVIEW. THE DEVICE WAS USED FOR DELIVERY OF STEM CELLS AND PLATELET RICH PLASMA TO THE PT'S HIP; HOWEVER, THE DEVICE IS INDICATED FOR DELIVERY OF BONE CEMENT FOR FIXATION OF FRACTURES OF THE VERTEBRAL BODY IN VERTEBROPLASTY AND KYPHOPLASTY PROCEDURES. THE CANNULA HAS ONLY BEEN DESIGNED FOR THE INDICATED USE; ANY OTHER USE HAS NOT BEEN EVALUATED BY ARTHROCARE. THE IFU PROVIDES THE FOLLOWING INDICATION FOR USE: "THE PARALLAX CLEAR-VIEW ACCESS NEEDLES ARE INTENDED FOR USE WITH THE CEMENT DELIVERY SYSTEMS FOR THE FIXATION OF PATHOLOGICAL FRACTURES OF THE VERTEBRAL BODY USING VERTEBROPLASTY OR KYPHOPLASTY PROCEDURES. PAINFUL VERTEBRAL COMPRESSION FRACTURES MAY RESULT FROM OSTEOPOROSIS, BENIGN LESIONS (HEMANGIOMA), AND MALIGNANT LESIONS (METASTATIC CANCER, MYELOMA)".

    Description of Event or Problem · 1

    DURING AN AVASCULAR NECROSIS (AVN) HIP PROCEDURE, THE PARALLAX CLEARVIEW ACCESS NEEDLE BROKE OFF IN THE PT'S HIP. THE NEEDLE WAS USED TO DELIVER STEM CELLS AND PLATELET RICH PLASMA (PRP) UNDER FLUOROSCOPY TO THE PT'S HIP. THE PROCEDURE WAS PERFORMED IN AN OUT-PT FACILITY AND WERE NOT EQUIPPED TO REMOVE THE NEEDLE FROM THE PT'S HIP AND THE PT WAS REFERRED TO AN IN-PT FACILITY FOR THE REMOVAL OF THE BROKEN NEEDLE WITH AN ORTHOPEDIC SURGEON. THE REMOVAL OF THE NEEDLE WAS PERFORMED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARALLAX CLEARVIEW ACCESS NEEDLE CEMENT DISPENSER KDD ARTHROCARE CORP. M200753

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other