(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: 0001032347-2021-00013.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: 0001032347-2021-00013, 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 fossa component, small, part# 24-6563, lot# 972390d; 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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It was reported the patient experienced limited opening, pain, discomfort, tightness, swelling and infection on the left side eight (8) months following implantation of bilateral temporomandibular joint implants.No cultures have been taken and no medications or additional treatment have been administered.The patient¿s current condition was described as improved but still experiences discomfort, tightness and swelling.No revision is planned at this time.No additional patient consequences have been reported.
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