A surgeon alleged that one of a patient's magec rods appeared to not be distracting after over two (2) years of implantation.The patient was initially implanted with dual magec rods (4.5mm standard and 4.5mm offset rod) on (b)(6) 2013.It was alleged that the 4.5mm standard rod was not distracting.The surgeon decided to remove both magec rods on (b)(6) 2016; however, the 4.5mm offset rod was fully functional.The patient was implanted with new dual magec rods without further incident.To date, the patient is doing fine and continuing treatment with magec.No negative outcomes have been reported.A dhr review revealed that there were no deviations from the manufacturing process, and the device was released within specifications.
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