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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Pre-operative diagnosis: spinal kyphoscoliosis, procedure: oblique lumbar interbody fusion (olif), level implanted: l3/4,l4/l5.It was reported that intra-op, when inserting the screw, the physician pulled the screw out immediately and checked again with the filler, and it was found that the medial side seemed to be ruptured by the screw.Since blood pressure decreased immediately, wound closure was performed.There was no malfunction reported for the product.It was suspected that superior gluteal artery seemed to be injured by judging from the direction.The product came in contact with the patient.
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