This product is not marketed in us but a similar device with product number c01a with 510(k)# k041584 and udi (b)(4) is marketed in us.Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
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Information was received from healthcare provider (hcp) via a manufacturer representative regarding a patient implanted bone cement using bkp.Pre-operative diagnosis for this procedure was primary osteoporosis.Fracture type: compression fracture.Patient medical history: cancer of lung.It was reported that after inflating the vertebral body with balloon according to the bkp surgical technique, the vertebral body was filled with cement with bfd that was mixed with the mixer.It was said that the viscosity of the cement was not problematic 8 minutes after mixing.Postoperative ct scan showed cement leakage into the blood vessels.It was said that upon examination, pulmonary embolus was observed, but there were no symptoms, and the pain had disappeared, and the course was smooth.There was an overflow.It looked like polymerized cement had flowed from the basivertebral veins in the vertebral body.The cement was stored at correct temperature and mixed for 30-45 seconds.The cement was doughy and homogenous prior to delivery into the patient.The procedure was performed successfully by using the reported product.No patient symptoms or complications as a result of this event.
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