(b)(4).Multiple mdr's were filed for this event.Please see associated report(s): 0001825034 - 2019 - 02469, 0001825034 - 2019 - 02470, 0001825034 - 2019 - 02471, 0001825034 - 2019 - 02472, 0001825034 - 2019 - 02473, 0001825034 - 2019 - 02474, 0001825034 - 2019 - 02475, 0001825034 - 2019 - 02476, 0001825034 - 2019 - 02477, 0001825034 - 2019 - 02480, 0001825034 - 2019 - 02481, 0001825034 - 2019 - 02482, 0001825034 - 2019 - 02483, 0001825034 - 2019 - 02484, 0001825034 - 2019 - 02485, 0001825034 - 2019 - 02486, 0001825034 - 2019 - 02487.Concomitant medical products, associated device(s), primary di# item #: 51-104160, item name: tprlc 133 t1 pps ho 16x152mm, lot number: 3817553, primary di#: (b)(4).51-104160, tprlc 133 t1 pps ho 16x152mm, 6028661, (b)(4).51-104140, tprlc 133 t1 pps ho 14x148mm, 3817531, (b)(4).51-103180, tprlc 133 t1 pps so 18x156mm, 3975978, (b)(4).51-103180, tprlc 133 t1 pps so 18x156mm, 6022911, (b)(4).51-103170, tprlc 133 t1 pps so 17x154mm, 6238743, (b)(4).51-103170, tprlc 133 t1 pps so 17x154mm, 6133628, (b)(4).51-103160, tprlc 133 t1 pps so 16x152mm, 6309256, (b)(4). 51-103150, tprlc 133 t1 pps so 15x150mm, 6118653, (b)(4).51-103140, tprlc 133 t1 pps so 14x148mm, 6075801, (b)(4).51-103140, tprlc 133 t1 pps so 14x148mm, 6170567, (b)(4).51-103130, tprlc 133 t1 pps so 13x146mmtp, 6308779, (b)(4).51-103090, tprlc 133 type1 pps so 9x137mm, 6462370, (b)(4).51-100080, tprlc 133 fp type1 pps so 8.0, 6364712, (b)(4).51-100060, tprlc 133 fp type1 pps so 6.0, 6289409, (b)(4).51-100060, tprlc 133 fp type1 pps so 6.0, 6273744, (b)(4).51-100050, tprlc 133 fp type1 pps so 5.0, 6241443, (b)(4).51-100040, tprlc 133 fp type1 pps so 4.0, 6246127, not released.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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