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.
|
It was reported that the patient underwent balloon kyphoplasty due to compression fracture.Intra-op, when the physician deflated the inflatable bone tamp (ibt) and was removing it, the balloon portion detached from the ibt.The balloon portion remained in the vertebral body.No patient complications have been reported.
|