BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSEOPERM 1.0 BONE CEMENT

    MDR report key: 1760581 · Received July 14, 2010

    Report

    Report Number
    3007111981-2010-00001
    Event Type
    Injury
    Date Received
    July 14, 2010
    Date of Event
    June 12, 2010
    Report Date
    June 16, 2010
    Manufacturer
    OSSEON THERAPEUTICS INC.
    Product Code
    NDN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXTRAVASATION WAS A FUNCTION OF PT VERTEBRAL PHYSIOLOGY AND NOT A FUNCTION OF DEVICE PERFORMANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED, A PT UNDERWENT A PROCEDURE TO REPAIR L4 ON (B)(6). DURING THE PROCEDURE, A BONE CEMENT EXTRAVASATION OCCURRED. UPON COMPLETION OF PROCEDURE, PT REPORTED NO PAIN AND WAS RELEASED. ON (B)(6), THE PT COMPLAINED OF LEG PAIN. THE PHYSICIAN ORDERED A CT SCAN FOR (B)(6). THE CT SCAN SHOWED A SMALL AMOUNT OF CEMENT POSTERIOR AND COMPRESSING A NERVE ROOT. THE PHYSICIAN PERFORMED A PROCEDURE TO REMOVE CEMENT COMPRESSING THE NERVE ROOT. ON (B)(6)2010, PT WAS STILL COMPLAINING OF LEG PAIN. AS OF (B)(6)2010, PT WAS STILL COMPLAINING OF SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSSEOPERM 1.0 BONE CEMENT OSSEOPERM 1.0 NDN OSSEON THERAPEUTICS INC. OP-0001 OP-006

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention