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.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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It was reported that the patient underwent balloon kyphoplasty surgery due to vetebral compression fractures.Intra-op, after deflating the balloon and removing through the introducer, the balloon itself detached from the shaft.Doctor had to pull very hard to get it out.The balloon remained inside the vertebral body (vb) with the cement.Doctor decided that it was related to how much hard the bone was inside the vb.No patient complication were reported as a result of this event.No additional surgery was performed to remove the balloon from the patient's body.
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