Zimmer biomet (b)(4).The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00013, 0001032347-2021-00014, 0001032347-2021-00044, 0001032347-2021-00045, 0001032347-2021-00046, 0001032347-2021-00047, 0001032347-2021-00049, 0001032347-2021-00050, 0001032347-2021-00051, 0001032347-2021-00052, 0001032347-2021-00053, 0001032347-2021-00054, 0001032347-2021-00055.D4 ¿ there are two (2) possible part numbers that were included on the invoice for the implantation surgery of bilateral temporomandibular joint devices; however, the event concerns the left side temporomandibular joint devices and it is unknown which part numbers were involved in this event.The part number is one of the following: item#: 91-2708, lot#: ni, serial#: ni, udi: (b)(4).Or item#: 91-2710, lot#: ni, serial#: ni, udi: (b)(4).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; 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 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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