BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTOSS BONE AUGMENTATION MATERIAL

    MDR report key: 2307412 · Received September 28, 2011

    Report

    Report Number
    2530131-2011-00008
    Event Type
    Malfunction
    Date Received
    September 28, 2011
    Report Date
    August 30, 2011
    Manufacturer
    ORTHOVITA, INC.
    Product Code
    NDN
    PMA / PMN Number
    K080108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REPEATED REQUEST, NO FURTHER INFORMATION WAS GIVEN. HOWEVER, IT WAS NOTED IN INITIAL CORRESPONDENCE THAT THE PHYSICIAN STATED HE WOULD NOT BE ABLE TO PERFORM FURTHER CASES IN THE ABSENCE OF A SECOND C-ARM WHICH INDICATES THAT THE PHYSICIAN IS ONLY USING ONE PLANE FLUOROSCOPY. IT IS NOTED IN THE CORTOSS INSTRUCTIONS FOR USE THAT "THE USE OF BIPLANAR IMAGING IS ALSO RECOMMENDED. THIS WILL HELP MINIMIZE THE CONTINUOUS RISK THROUGHOUT THE INJECTION OF POSSIBLE LEAKS OF CORTOSS MATERIAL INTO THE SPINAL CANAL, NEURAL FORAMINA, PARAVERTEBRAL SOFT TISSUES, ADJACENT DISCS, EPIDURAL SPACE OF THE VERTEBRAL COLUMN, ARTICULAR SPACES, SOFT TISSUES OR THE VENOUS SYSTEM." DUE TO LACK OF INFORMATION AND THE POTENTIAL FOR INJURY FOLLOWING EXTRAVASATION, IT WAS DETERMINED THAT THIS WAS MDR REPORTABLE. SHOULD ANY FURTHER INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED. METHOD: NO DEVICE TESTING PERFORMED. RESULTS: NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED.

    Description of Event or Problem · 1

    A SALES AGENT REPORTED 'INCREASED EXTRAVASATION INCIDENTS' ON BEHALF OF A PHYSICIAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other