BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORTOSS BONE AUGMENTATION MATERIAL

    MDR report key: 1887078 · Received November 1, 2010

    Report

    Report Number
    2530131-2010-00001
    Event Type
    Injury
    Date Received
    November 1, 2010
    Report Date
    September 15, 2010
    Manufacturer
    ORTHOVITA, INC.
    Product Code
    NDN
    PMA / PMN Number
    K080108
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT EXPERIENCED A PULMONARY EMBOLI FOLLOWING A VERTEBROPLASTY PROCEDURE. IN RESPONSE, AN ORTHOVITA MEDICAL REPRESENTATIVE VISITED THE USER AND REVIEWED THE PROPER DELIVERY TECHNIQUE OF THE DEVICE. IT WAS DETERMINED THAT THE USER WAS NOT USING LIVE FLUOROSCOPY PER THE INSTRUCTIONS FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORTOSS BONE AUGMENTATION MATERIAL CEMENT, BONE, VERTEBROPLASTY NDN ORTHOVITA, INC. 2101-0010

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization