It was reported that in (b)(6) 2010, the patient sustained a right humerus fracture and she underwent a fusion surgery with a plate.Several month later, the bone broke again and the patient had another fusion surgery with plate and screws.In (b)(6) 2012, bone broke again and she underwent fusion surgery using rhbmp-2/acs.Post-op, the patient has developed joint deterioration, swelling, pain, eye problems, a lesion on her skin, and extreme fatigue.Patient is undergoing many tests to determine the cause of her symptoms, but no answer has been found.Her blood work was negative for lupus and rheumatoid arthritis.The patient has seen a lung specialist, a dermatologist, an eye specialist, and an orthopedic surgeon.The orthopedic surgeon reportedly said that "something is attacking her joints." an mri reportedly indicated that "something is attacking her joints" and the physician thinks there is an autoimmune problem.No additional information was provided.
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(b)(4).Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Products from multiple manufacturers were implanted during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.
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