D10: concomitants: serial number item number and full description: (b)(4) - equinoxe preserve stem 6mm (b)(4) - glenosphere, 36mm (b)(4) - small superior augment glenoid plate (b)(4) - 145-deg pe 36mm hum liner +2.5 additional information, including the product investigation, will be submitted within 30 days of receipt.
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It was reported via a clinical equinoxe shoulder study, that a 65 yo female patient, initial right shoulder implanted on (b)(6)2022, had increased onset of pain posteriorly with no mechanism of injury reported.A scapular spine fracture, (type 2), was indicated.Date of onset was (b)(6)2022.The patient underwent a bone density test.They were prescribed a sling, rest, tramadol, calcium and vitamin d supplements.The study indicated the event was definitely related to the device and the procedure.The outcome states resolved on august 7, 2023.The scapular spine stress fracture is still visible on x-ray, declared nonunion, and the patient is pain free and functioning at a baseline once again.No further information.
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