No product was returned and no radiographs were provided confirming the alleged complaint.It is unknown what the patients post activity levels were or whether they experienced a fall or other accident.Review of the reported event identified the patient has a history of spinal procedures and pseudarthrosis.It is unknown if the patient is a smoker.Review of all provided information indicates the root cause of the rod fracture to be the result of an extended period (3 plus years) of non fusion resulting excessive loading and device failure.No additional investigation required.Labeling review: ".Contraindications - contraindications include, but are not limited to: patients with inadequate bone stock or quality." ".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, nonunion or delayed union." ".Warnings, cautions and precautions - the safety and effectiveness of this device has not been established for use as part of a growing rod construct.This device is only intended to be used when definitive fusion is being performed at all instrumented levels." ".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." ".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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