The reported event was confirmed by review of the radiographic image provided.No product was returned to nuvasive for evaluation as the device remains in-situ.Operative notes were not provided for review of usage/technique.A definitive root cause was unable to be determined with the information provided.There are warnings in the device labeling that this type of event can occur: "potential adverse events and complications: potential risks identified with the use of this system, which may require additional surgery, include: fracture of the vertebra"."warnings, cautions and precautions: the implantation of spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient".If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
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