No device was returned for evaluation as the only device removed was discarded at user facility.Radiographs provided confirm lock screw back out.No lab reports were provided to confirm an infection.Nuvasive devices were cleaned and sterilized by user facility prior to the case and no sterilization records were provided.The root cause of the reported event cannot be determined, however review of the received information suggests the nosocomial infection is possibly the result of environmental contamination and the lock screw back out is likely the result of cross-threading or insufficient torque.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.Infrequent operative and postoperative complications that may result in the need for additional surgeries include: early or late infection.Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s), infection." ".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.Care should be taken to insure that all components are ideally fixated prior to closure." ".Pre-operative warnings: care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." ".Packaging: packages for each of the components should be intact upon receipt.Devices should be carefully examined for completeness, and for lack of damage, prior to use.Damaged packages or products should not be used, and should be returned to nuvasive.The instruments and implants of the system may be supplied as either sterile or non-sterile.All implants provided non-sterile are single use and should be sterilized per instructions provided below.Instruments provided non-sterile can be single-use or reusable.Discard single-use instruments after use.Reusable instruments should be reprocessed using instructions provided below.All implants and instruments provided sterile are intended for single use only.Do not use if package is opened or damaged.This product should not be re-sterilized.Discard single-use instruments after use." ".Handling of the sterile implant: before removing the implants from the package, make sure that the protective packaging is unopened and undamaged.If the packaging is damaged, the implants have to be considered as non-sterile and may not be used.Upon removal from the package, compare the descriptions on the label with the package contents product number and size.Note the sterile expiry date.Implants with elapsed sterile expiry dates have to be considered as non-sterile.Take particular care that aseptic integrity is assured during removal of the implant from the inner packaging.Open the packages carefully.Take suitable measures to ensure that the implant does not come into contact with objects that could damage its surfaces.Use only the recommended instruments for implantation of the implants.Damaged implants must not be used." ".Cleaning and decontamination: all non-sterile instruments must first be thoroughly cleaned using the validated methods prescribed in the nuvasive cleaning and sterilization instructions doc 9400896 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.Instruments with a d prefix part number may be disassembled.Please refer to the additional disassembly instructions for these instruments." ".Sterilization: all non-sterile instruments and implants are sterilizable by steam autoclave using standard hospital practices, in addition to nuvasive¿s validated parameters.In a properly functioning and calibrated steam sterilizer, effective sterilization may be achieved using the parameters prescribed in the nuvasive cleaning and sterilization instructions doc 9400896.".
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