Adverse outcome: others: excessive bleeding.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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It was reported that the patient presented with kyphosis and t10 vertebral body fracture; and underwent posterior fixation at t7-l3 after t10 vertebral column resection (vcr).Intra-op, after vcr was performed at t10 and cylinder of 13mm was placed at t2, x-ray (taken at the time of posterior fixation) revealed that the cage did not connect with the endplate of t9.The cranial side of the cage had deviated towards the anterior side of the t9 vertebral body and bleeding occurred.Since the image had not been confirmed when placing the cage, it was considered that there was a high possibility that the initial placing position was originally at the anterior side.Because of a large amount of bleeding, the surgeon decided to give up doing the operation such as re-placement of the cage, and wound closure was performed after finishing the posterior fixation.The end cap was not used.It was said that the cage seemed to be not contracted.The patient's condition was not confirmed.There was delay of more than 60 minutes in overall procedure.The assistant surgeon considered that it was not an injury to the blood vessels etc.
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