No product has been returned for investigation as no product malfunction has been reported.At this time it is unknown what caused the alleged event.Labeling review: ".Potential risks identified with the use of this system, which may require additional surgery, include: infection." cleaning and decontamination: ".All non-sterile instruments must first be thoroughly cleaned using the validated methods prescribed in the nuvasive cleaning and sterilization instructions ((b)(4)) before sterilization and introduction into a sterile surgical field.Contaminated instruments should be wiped clean of visible soil at the point of use, prior to transfer to a central processing unit for cleaning and sterilization.The validated cleaning methods include both manual and automated cleaning.Visually inspect the instruments following performance of the cleaning instructions to ensure there is no visual contamination of the instruments prior to proceeding with sterilization.If possible contamination is present at visual inspection, repeat the cleaning steps.Contaminated instruments should not be used, and should be returned to nuvasive.Contact your local representative or nuvasive directly for any additional information related to cleaning of nuvasive surgical instruments." no device problem reported.
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