The ex-planted devices were returned and inspected and no product defect or failure was identified.Review of provided radiographs, contact marks and surgeon feedback suggests a combination of installation difficulties and anatomical changeless may have resulted in excessive load and connector separation.Labeling review: ".All set screws should be final-tightened with the counter- torque and torque t-handle.Do not final-tighten through compression instruments in the set, as the rod may not be able to normalize to the tulip." ".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.Be cautious not to over compress or distract as you can loosen the screws in the spine and potentially pull out the screw.The bulleted portion of the nose of the rod and the faceted portion of the rod (where the inserter locks down on the rod) must extend fully outside of the most inferior or most superior tulip on the construct.The set screw cannot be locked down on this unusable portion of the rod, as this may compromise the stability of the construct." ".Care should be taken to insure that all components are ideally fixated prior to closure.All implants should be used only with the appropriately designated instrument." ".Potential risks identified with the use of this system, which may require additional surgery, include: ¿ bending, fracture or loosening of implant component(s).".
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