No device has been returned for evaluation and no radiographs were provided to confirm the complaint.No torque information provided and it is unknown if the surgeon utilized hand tightening.Dhr review of the reported device identified with release to the field in 2016.Review of the reported information suggests age wear fatigue, off-angled excessive force and/or excessive torque applied from out of calibration torque handle or hand tightening as the root cause.No additional investigation can be completed at this time, should more information be received a follow-up report will 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: bending, fracture or loosening of implant components." ".Warnings, cautions and precautions: all lock screws should be final-tightened with the counter-torque and torque t-handle.Do not implant the instruments: complications to the patient may include, but are not limited to: nerve damage, paralysis, pain, or damage to soft tissue, visceral organ, or joints.Dural leak in cases of excessive load application or impingement of close vessels, nerves, and/or organs by slippage or misplacement of the instrument.Bony fracture, especially in the case of deformed spine or weak bone.Infection, if instruments are not properly cleaned and sterilized.Breakage of the device, which could make necessary removal difficult or sometimes impossible, with possible consequences of late infection and migration.Breakage could cause injury to the patient.Pain, discomfort, or abnormal sensations resulting from the presence of the device." ".Pre-operative warnings: care should be used during surgical procedures to prevent damage to the devices and injury to the patient." ".Intra-operative warnings: the physician should take precautions against putting undue stress on the spinal area with instruments.Any surgical technique should be carefully followed.It is important that the surgeon exercise extreme caution when working in close proximity to vital organs, nerves, or vessels, and that the force applied to the instrumentation is not excessive, to prevent potential injury to the patient.Over-bending, notching, striking, and/or scratching of implants with any instrument should be avoided to reduce the risk of breakage.When using the maxcess mas tlif system for distraction care must be taken to avoid damaging the pedicles which could compromise pedicle screw purchase.The physical characteristics required for many instruments do not permit them to be manufactured from implantable materials.If any broken fragments of instruments remain in the body of a patient, they could cause allergic reactions or infections.If an instrument breaks in surgery and fragments go into the patient, these pieces should be removed prior to closure and should not be implanted." ".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.".
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