(b)(4).Multiple mdrs were filed in association with this event.Please see: 0001825034-2019-02792, 0001825034-2019-02793, 0001825034-2019-02794, 0001825034-2019-02799, 0001825034-2019-02800, 0001825034-2019-02801, 0001825034-2019-02802, 0001825034-2019-02803, 0001825034-2019-02804, 0001825034-2019-02805, 0001825034-2019-02806, 0001825034-2019-02807.Concomitant medical products: 908646, washerloc cortical screw 46mm, lot 305460; 906513, tunneloc fixation, lot 465065; 904781, standard ezloc, lot 576530; 904755, ziploop, lot p08647; 904056, ez pass, lot 545450; 904055, ez pass, lot 359600; 904053, ez pass, lot 048410; 900321, maxfire, lot 909090; 904760, toggle drill, lot 699980; 912031, juggerknot, lot p09905; 912029, juggerknot, lot p08797.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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