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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M120401006, the information was received from the clinical department for a patient regarding a spinal therapy.It was reported that the patient had osteoporotic fracture.Osteoporotic fracture of l4, l5, subsidence of cages, l4 screw displacement in fracture into disc l3/4.No clinical symptoms.Was assessment for product/therapy/procedure relatedness made by the investigator - yes relevant assessment/allegation: probably related to the progression of degenerative lumbar spine was assessment for product/therapy/procedure relatedness made by the sponsor - yes was an assessment for product/therapy/procedure relatedness made by the cec - no ae outcome: ongoing relevant patient medical history: -hypertension -renal insufficiency -coronary heart disease -cancer -respiratory disease (copd, asthma) -depression / anxiety medications: anti-epileptic medications ae description: probably no consequence to implanted device - bone condition problem.Ae diagnosis: osteoporotic fracture l4, l5.
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