While this device has gained initial pma approval, it has not been commercialized, imported or sold in the us and no implantations have been performed as of the date of this report.The implant neuro zti evo was not explanted as of the date of this report.Currently, this event is not a serious injury.Follow-up report will be submitted if the device explanted.The subject device is part of the voluntary field corrective action initiated for neuro zti on october 14th 2021 (international recall # (b)(4)).
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