Other: non-union.Only year valid.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 per patient call that in 2008, the patient underwent "csp" fusion at c3-c5, in which rhbmp-2/acs was implanted.On an unknown date, post-op, non-union was observed at c5.As a result of this event, patient underwent two revision surgeries.No additional information is available at this moment.
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