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The fractured rods were left in-situ, no radiographs or images were provided so the complaint could not be confirmed.It is unknown if the patient followed post operative physical restrictions or suffered a fall.The patients bone quality is unknown.Review of the reported event identified the posterior fixation has been in place for over five years and it is unknown if fusion was completed at the instrumented levels.The root cause of the event is considered component failure as the fractured rods had been loaded for over five years that can result in fatigue failure as noted in the instructions for use, these load sharing devices are expected to be unloaded as newly formed bone mass is developed within the 2.5 years of expected lifetime.No additional investigation can be completed.Manufacturing review: no material or lot code information was provided so a complete manufacturing review could not be completed.Labeling review: "contraindications: contraindications include, but are not limited to.4.Patients who are unwilling to restrict activities or follow medical advice.5.Patients with inadequate bone stock or quality.6.Patients with physical or medical conditions that would prohibit beneficial surgical outcome.7.Reuse or multiple uses." "potential adverse events and complications.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, nonunion or delayed union.Decrease in bone density due to stress shielding, pain, discomfort or abnormal sensations due to the presence of the device." "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." ".Correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant.While proper selection can minimize risks, the size and shape of human bones present limitations on the size and strength of implants.Metallic internal fixation devices cannot withstand the activity levels and/or loads equal to those placed on normal, healthy bone.These devices are not designed to withstand the unsupported stress of full weight or load bearing alone." ".These devices can break when subjected to the increased load associated with delayed union or nonunion.Internal fixation appliances are load-sharing devices that hold bony structures in alignment until healing occurs.If healing is delayed, or does not occur, the implant may eventually loosen, bend, or break.Loads on the device produced by load bearing and by the patient¿s activity level will dictate the longevity of the implant.Corrosion of the implant can occur.Implanting metals and alloys in the human body subjects them to a constantly changing environment of salts, acids, and alkalis, which can cause corrosion.Placing dissimilar metals in contact with each other can accelerate the corrosion process, which in turn, can enhance fatigue fractures of implants.Consequently, every effort should be made to use compatible metals and alloys in conjunction with each other." "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." "single use/do not re-use: reuse of a single use device that has come in contact with blood, bone, tissue or other body fluids may lead to patient or user injury.Possible risks associated with reuse of a single use device include, but are not limited to, mechanical failure, material degradation, potential leachables, and transmission of infectious agents." "pre-operative warnings 1.Only patients that meet the criteria described in the indications should be selected.2.Patient condition and/or predispositions such as those addressed in the aforementioned contraindications should be avoided." "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." "information to obtain a surgical technique manual or should any information regarding the products or their uses be required, please contact your local representative or nuvasive directly at." 9401879-en p-12/2018 "lifetime of the device: vuepoint, armada, leverage, helix, reline, mas plif fixation (precept): the expected life cycle of implants is determined through astm f1717 testing (astm f1717 standard test methods for spinal implant constructs in a vertebrectomy model).5 million cycle endurance limit in astm f1717 represents 2.5 years of in vivo usage per the rationale presented here: "the purpose of spinal fusion implants is to provide short term stability until arthrodesis takes place.Following fusion, the device is expected to be unloaded due to load-sharing with the newly formed bone mass.Spinal fusion should occur within 12 months of surgery.¿ according to hedman¸ et al.(1991), the average person makes approximately 2 million strides per year (1 million gait cycles).Testing to 5 million cycles is equivalent to a lifetime of approximately 2.5 years of activity, providing a safety factor of 2.5." h3 other text : left in-situ.
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