Radiograph confirmed the event.The initial surgery date was not provided.The device remains in-situ.No further evaluation can be done at this time.Review of labeling notes: warning cautions and precautions: "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, fracture of the vertebra." "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.".
|