(b)(4).The investigation is in process.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: 0001032347-2021-00014.Concomitant medical products: tmj system left fossa component, small, part# 24-6563, lot# 972390d.Tmj system left standard mandibular component 50mm / 9 hole, part# 24-6551, lot# 819000a.Unknown screws, part# ni, lot# ni.
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This follow-up report is being submitted to relay additional information.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00014, 0001032347-2021-00044, 0001032347-2021-00045, 0001032347-2021-00046, 0001032347-2021-00047, 0001032347-2021-00048, 0001032347-2021-00049, 0001032347-2021-00050, 0001032347-2021-00051, 0001032347-2021-00052, 0001032347-2021-00053, 0001032347-2021-00054, 0001032347-2021-00055.D11 ¿ medical products: tmj system left standard mandibular component 50mm / 9 hole, part# 24-6551, lot# 819000a, 2.4mm system high torque (ht) cross-drive screw 2.7mm x 8mm, part# 91-2708, lot# ni, 2.4mm system high torque (ht) cross-drive screw 2.7mm x 10mm, part# 91-2710, lot# ni, tmj system cross drive fossa screw 2.0mm x 7mm, part# 99-6577, lot# ni, tmj system cross drive fossa screw 2.0mm x 9mm, part# 99-6579, lot# ni, unknown mandible screw, part# ni, lot# ni, unknown mandible screw, part# ni, lot# ni, unknown mandible screw, part# ni, lot# ni, unknown mandible screw, part# ni, lot# ni, unknown fossa screw, part# ni, lot# ni, unknown fossa screw, part# ni, lot# ni, unknown fossa screw, part# ni, lot# ni, unknown fossa screw, part# ni, lot# ni.
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