BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STABILIT ER2 BONE CEMENT

    MDR report key: 1944449 · Received December 18, 2010

    Report

    Report Number
    3006396387-2010-00001
    Event Type
    Injury
    Date Received
    December 18, 2010
    Date of Event
    November 19, 2010
    Report Date
    December 17, 2010
    Manufacturer
    DFINE INC.
    Product Code
    NDN
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE MADE. NO PRODUCT WAS RETURNED FOR ROOT CAUSE ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE LOT MET ALL SPECIFICATION REQUIREMENTS PRIOR TO RELEASE. NO REPORTED PATIENT INJURY OCCURRED. AS AN EVENT OF THIS NATURE COULD RESULT IN THE NEED FOR SURGICAL INTERVENTION WERE IT TO RECUR AN MDR IS BEING FILED.

    Description of Event or Problem · 1

    AN ANTERIOR EXTRAVASATION WAS NOTICED DURING A LATERAL FLUOROSCOPY THAT WAS TAKEN AT THE END OF THE PROCEDURE. THE EVENT AS REPORTED WAS NOT ATTRIBUTED TO THE DEVICE. THE EVENT THAT OCCURRED IS A KNOWN RISK OF VERTEBROPLASTY AND KYPHOPLASTY. AT THIS TIME, NO CONNECTION CAN BE MADE BETWEEN THE INCIDENT AND ANY SHORTCOMING OF THE DEVICE OR OF INFORMATION SUPPLIED WITH THE DEVICE. NO REPORTED PATIENT INJURY OCCURRED. AS AN EVENT OF THIS NATURE COULD RESULT IN THE NEED FOR SURGICAL INTERVENTION WERE IT TO RECUR AN MDR IS BEING FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STABILIT ER2 BONE CEMENT BONE CEMENT NDN DFINE INC. 1135 DF019

    Patients

    Seq Age Sex Outcome Treatment
    1 Other