The patient was implanted with dual magec rods (lot# a150128-11; manufacture date 01/02/2015, expiration date 01/02/2017, and lot# a150319-22; manufacture date 03/01/2015, expiration date 03/01/2017), and it was alleged that the rods appeared to not be distracting.The rods were removed on (b)(6) 2016, and the patient was implanted with new dual magec rods without incident.To date, the patient is doing fine and no negative outcomes have been reported.A dhr review revealed that there were no deviations from the manufacturing process, and the devices were released within specifications.
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