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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Information was received from a healthcare provider via a manufacturer representative regarding a patient with pre-operative diagnosis of primary osteoporosis.It was reported that intra-op, during balloon inflation, it was noted that the balloon ruptured and contrast media leaked.After that, no inflation was performed additionally, the cement was filled as it was, but the cavity was not formed well and the cement content was not so filled as compared with the undamaged left cavity.There was no patient complications/symptoms associated with the event.
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