No dual magec rods from numbers (b)(4) were implanted in the patient on (b)(6), 2014.It was confirmed that the rods were fully functional; however, the patient was presented with a localized infection.The magec rods were removed some time prior to (b)(6), 2014 and the patient was implanted with two (2) new magec rods after treatment of the infection, without incident.To date, the patient is doing well and has fully recovered.The devices have yet to be returned; therefore, no evaluation can be conducted at this time.A dhr review revealed that there were no deviations from the manufacturing process and that the devices were released within specifications.
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