No product was received as the involved devices were disposed of at the user facility.No radiographs could be provided confirming alleged incident.It was confirmed in the initial reporting the patient has experienced a fall resulting in the root cause of the pulled out screws.No additional investigation required.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." potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s), loss of fixation." ".Patient education: preoperative instructions to the patient are essential.The patient should be made aware of the limitations of the implant and potential risks of the surgery.The patient should be instructed to limit postoperative activity, as this will reduce the risk of bent, broken or loose implant components.The patient must be made aware that implant components may bend, break or loosen even though restrictions in activity are followed." ".Post-operative warnings - during the postoperative phase it is of particular importance that the physician keeps the patient well informed of all procedures and treatments.Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration, as well as to other complications.To ensure the earliest possible detection of such catalysts of device dysfunction, the devices must be checked periodically postoperatively, using appropriate radiographic techniques.".
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This follow-up report is being submitted to relay additional information.The following sections were the reported event was unable to be confirmed due to limited information received concerning this event.No device was returned to nuvasive for evaluation; further, no operative notes and/or radiograph images were provided for review of usage/technique.A review of manufacturing records was unable to be performed as the part and lot information of the product involved in the event was not available.A labeling review was unable to be performed as the nuvasive product involved was not provided.It was noted that the patient experienced a fall and subsequently the pulled out screws were identified.It is unknown if the patient's fall caused the screws to pull out or if the pulled out screws contributed to the fall event.A definitive root cause was unable to be determined with the information provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
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