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.If information is provided in the future, a supplemental report will be issued.
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It was reported that the patient underwent cervical fusion.Post op, patient had to have all her teeth pulled, she had sinus surgery, neurological ectopic bone overgrowth, lupus, cyst/nodules in every organ except appendix and spleen, she¿s been in a coma, has dementia, butterfly rash on face and back and she breaks out in blisters.Multiple surgeries and blood test were performed as the result of the event.
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