(b)(4).Concomitant medical products: distal lateral fibular plate left 6 holes 106 mm length, pn: 47235701806, ln: 63550687; 2.7 mm locking screw 14 mm length, pn: 47482801402, ln: 63671062; 2.7 mm locking screw 16 mm length, pn: 47482801602, ln: 63869781; 2.7 mm locking screw 12 mm length, pn: 47482801202, ln: 63861780; 2.7mm locking screw 12mm long, pn: unk, ln: 62348896; 2.7 mm locking screw 18 mm length, pn: 47482801802, ln: 63861772; cortical bone screw self-tapping hex head 3.5 mm diameter 18 mm length, pn: 47234801835, ln: 63098016; cortical bone screw self-tapping hex head 3.5 mm diameter 12 mm length, pn: 47234801235, ln: 63406688; cortical bone screw self-tapping hex head 3.5 mm diameter 40 mm length, pn: 47234804035, ln: 61168845; cortical bone screw self-tapping hex head 3.5 mm diameter 46 mm length, pn: 47234804635, ln: 61214651.Report source: foreign - (b)(6).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2019-00655, 0001822565-2019-00656, 0001822565-2019-00657, 0001822565-2019-00658, 0001822565-2019-00659, 0001822565-2019-00660, 0001822565-2019-00662, 0001822565-2019-00663, 0002648920-2019-00109, 0002648920-2019-00108.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.Device evaluated by mfr? product not returned.
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