(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, 0001825034-2019-02802, 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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