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.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Pre-op diagnosis: multiple myeloma it was reported that on (b)(6) 2016, intra-op during balloon kyphoplasty, balloon burst in the vertebral body after inflating, cement was filled up as it was, surgeon waited for the cement to harden and surgery was finished.No patient complications were reported.Balloon kyphoplasty was performed at three levels, th11- l1.The balloon got damaged when it was inflated around 300 psi at right th12.Then cement was inserted without cleaning the surgical field.It was unknown which lot was damaged.The patient had bone sclerosis and surgeon told bones were hard.No complication was reported, the fragment remained in the patient though.
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