No product was received or returned as no product malfunction was reported and the involved devices currently remain in situ.No radiographs or testing data was provided confirming the reported blood clot.The root cause of the event is unknown but could be the result of inadvertent contact and tissue damage.Note nuvasive posterior fixation was utilized in conjunction with another manufactures cages and likely is a cause or contributor, and is considered to be off label usage.No additional investigation can be completed at this time.Label review: potential adverse events and complications.As with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries include: damage to blood vessels." ".Potential risks identified with the use of this system, which may require additional surgery, include: neurological, vascular or visceral injury, pain, discomfort or abnormal sensations due to the presence of the device." ".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." ".Compatibility: do not use the reline system with components of other systems, other than the armada system.Refer to the armada system instructions for use for a list of the armada system indications for use.Unless stated otherwise, nuvasive devices are not to be combined with the components of another system.All implants should be used only with the appropriately designated instrument (reference surgical technique)¿".
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