BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STABILIT ER BONE CEMENT

    MDR report key: 2162165 · Received July 7, 2011

    Report

    Report Number
    3006396387-2011-00006
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 10, 2011
    Report Date
    July 7, 2011
    Manufacturer
    DFINE INC.
    Product Code
    NDN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF (B)(4), 2011, THE PATIENT WAS NOT EXPERIENCING ANY SCAPULAR PAIN. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY ANOMALY RELATED TO THE COMPLAINT. PRIOR TO RELEASE OF THE LOT, CHEMICAL AND MECHANICAL TESTS WERE PERFORMED. CHEMICAL AND MECHANICAL TEST RESULTS FOR THE LOT MET ALL SPECIFICATIONS. CEMENT LEAKAGE IS A KNOWN AND INHERENT RISK OF THE PROCEDURE. LEAKS CAN OCCUR DUE TO UNSEEN MICROFRACTURES. NO DEFINITIVE CONCLUSION CAN BE MADE AS TO WHY THE PATIENT WAS FEELING SCAPULAR PAIN.

    Description of Event or Problem · 1

    THE PHYSICIAN TREATED A PATIENT WITH A VERTEBRAL COMPRESSION FRACTURE DUE TO A SPINAL METASTASIS. THE PATIENT FOLLOWED UP WITH THE PHYSICIAN A WEEK AFTER THE PROCEDURE AND COMPLAINED OF SCAPULAR PAIN. MILD EXTRAVASATION OF BONE CEMENT WAS NOTICED BY THE PHYSICIAN DURING BONE CEMENT DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STABILIT ER BONE CEMENT BONE CEMENT NDN DFINE INC. 1135 DF025

    Patients

    Seq Age Sex Outcome Treatment
    1