Product was returned for evaluation.Review of the returned rods found a complete lack of final lock screw torque down contact markings, which indicates the 90-in lbs of required torque was not applied.No additional investigation required.Labeling review: "potential adverse events and complications: as with any major surgical procedures, there are risks involved in orthopedic surgery.Rarely, some complications may be fatal.Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s)." "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.These devices can break when subjected to the increased load associated with delayed union or nonunion.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.All lock screws should be final-tightened with the counter-torque and torque t-handle.Do not final-tighten through compression instruments (e.G.C/d rack and figure 8 compressor) in the set, as the rod may not be able to normalize to the tulip.Care should be taken to insure that all components are ideally fixated prior to closure." "post-operative warnings: damage to the weight-bearing structures can give rise to loosening of the components, dislocation, and migration, as well as to other complications.".
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On (b)(6) 2020, a patient underwent a spinal surgery at l4/5.Same day post-operative x-rays showed no evidence of any malfunctions.Three weeks post-op x-rays revealed a left side rod migration.On (b)(6) 2020, a revision surgery was performed where both rods, and tulips were replaced.
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