(b)(4).Multiple mdr's were filed for this event.Please see associated report(s): 0001825034 - 2018 - 11335, 0001825034 - 2018 - 11338, 0001825034 - 2018 - 11351, 0001825034 - 2018 - 11352, 0001825034 - 2018 - 11353, 0001825034 - 2018 - 11354, 0001825034 - 2018 - 11355, 0001825034 - 2018 - 11356.(b)(4).Concomitant medical products: item # 115397 comp rvs cntrl 6.5x35mm st/rst lot 351970, 180550 comp lk scr 3.5hex 4.75x15 st lot 115560, 010000589 comp rvrs 25mm bsplt ha+adptr lot 180780, 180551 comp lk scr 3.5hex 4.75x20 st lot 238420, 180551 comp lk scr 3.5hex 4.75x20 st lot 238400, 115310 comp rvrs shldr glnsp std 36mm lot 128420, 113634 comp primary stem 14mm mini lot 213860, 115370 comp rvs tray co 44mm lot 752390.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Not returned to manufacturer.
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