(b)(4).Concomitant medical product: flat titanium pectus bar 11" cat # jp-0110, lot # 283130, l-plt lt reg 2.0 lactosorb sys, cat # 915-2102, lot # 638640, battery powerdriver p2, cat# 50-1010, lot# 282330, battery powerdriver p2, cat#50-1010, lot# 282320, battery powerdriver p2, cat#50-1010, lot# 476000, battery powerdriver p2, cat#50-1010, lot# 579610, carroll-girard screw hex-end, cat# sp-2693, lot# 818880, lacto scr 1.5x4mm 1.5 sys 2pk, cat# 915-2315, lot# 727800, lactosorb1.5mm xshapeextplate, cat# 915-2423, lot# 832560, battery powerdriver p,2 cat# 50-1010, lot # 692220.Battery powerdriver p2, cat# 50-1010, lot# 003430, battery powerdriver p2, cat# 50-1010, lot# 003380, battery powerdriver p2, cat# 50-1010, lot# 760440, battery powerdriver p2, cat# 50-1010, lot# 657440, battery powerdriver p2, cat# 50-1010, lot# 657440, battery powerdriver p2, cat# 50-1010, lot# 657440, battery powerdriver p2, cat# 50-1010, lot# 760510, battery powerdriver p2, cat# 50-1010, lot# 760350 plate 4 hole with gap 2.0mm, cat# sp-2292, lot# 480680, ster trc tf 18.5mm bnt bur pl, cat# sp-st-1020b, lot# 147140, ster trc 2 xd tf 1.5x4.0mm scr, cat# sp-st2-6704, lot# 071120.Lacto scr 1.5x5mm 1.5 sys 2pk, cat# 915-2316, lot# 728470.Mfr site: foreign country: (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00441, 0001032347-2021-00442, 0001032347-2021-00443,,0001032347-2021-00444 0001032347-2021-00445, 0001032347 -2021-00446, 0001032347-2021-00447, 0001032347-2021-00448, 0001032347-2021-00449, 0001032347-2021-00450, 0001032347-2021-00452, 0001032347 -2021-00453, 0001032347-2021-00454, 0001032347-2021-00455, 0001032347-2021-00456, 0001032347-2021-00457, 0001032347-2021-00458, 0001032347 2021-00459, 0001032347-2021-00460, 0001032347-2021-00461, 0001032347-2021-00462, 0001032347-2021-00463.
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