BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFIDENCE SPINAL CEMENT SYSTEM

    MDR report key: 2253713 · Received August 19, 2011

    Report

    Report Number
    2253713
    Event Type
    Injury
    Date Received
    August 19, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 15, 2011
    Manufacturer
    DEPUY SPINE
    Product Code
    NDN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) FEMALE WAS ADMITTED FOR VERTEBROPLASTY SURGERY. HISTORY AND PHYSICAL INDICATED ALL BODY SYSTEMS WITHIN NORMAL LIMITS. PRE-OP LAB WORK WITHIN NORMAL LIMITS, EKG-NSR. PATIENT TO THE OPERATING ROOM ON (B)(6) 2011. ASA LEVEL II. TOWARDS THE END OF THE PROCEDURE ALMOST IMMEDIATELY AFTER THE LAST INJECTION OF BONE CEMENT WAS ADMINISTERED, THE PATIENT BECAME IMMEDIATELY HYPOTENSIVE. EMERGENCY MEDICATIONS WERE ADMINISTERED. THE PATIENT'S BP RETURNED. CT OF ABDOMEN/PELVIS WAS DONE - UNREMARKABLE. NO ABNORMALITIES TO ACCOUNT FOR THE PATIENT'S HYPOTENSION. CT OF SPINE DONE - CEMENT MATERIAL NOTED IN THE L-5 VERTEBRA AND L4-L5 DISC SPACE, L4 TO S1 FUSION AND L5 VERTEBROPLASTY. SUSPECTED FRACTURE OF THE RIGHT S1 PEDICLE SCREW. CT THORAX DONE - NO EVIDENCE FOR PULMONARY EMBOLISM. SMALL PERIPHERAL EMBOLI CANNOT BE EXCLUDED. METHACRYLATE EMBOLI MIGHT BE DIFFICULT TO IDENTIFY SINCE THERE ATTENUATION WOULD BE SIMILAR TO CONTRAST. PATIENT WAS TRANSFERRED TO ICU. PATIENT RECEIVED AGGRESSIVE VOLUME RESUSCITATION, IV EPINEPHRINE, LEVOPHED AND MECHANICAL VENTILATORY SUPPORT. PATIENT EXTUBATED ON (B)(6) 2011 EPINEPHRINE OFF. WALKING NEUROLOGICALLY INTACT (B)(6) 2011, BP RANGE 1050-132/56-73. DISCHARGED (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONFIDENCE SPINAL CEMENT SYSTEM BONE CEMENT NDN DEPUY SPINE 283903413 HMDBFW

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| L