No product was returned for evaluation.Review of the reported information states that competitor hardware was used simultaneously with nuvasive hardware which is an off-label use which is most likely the cause and/or contributor of the adverse event.The root cause cannot be determined.No additional investigation can be completed.Labeling review: "potential adverse events and complications: as with any major surgical procedures, there are risks involved in orthopedic surgery.Potential risks identified with the use of this system, which may require additional surgery, include nerve damage due to surgical trauma"."compatibility: unless stated otherwise, nuvasive devices are not to be combined with the components of another system".
|