Device fragment in patient.
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 that the patient presented with vertebral compression fracture at l1; and underwent balloon kyphoplasty.
Intra-op, when the physician was removing the inflatable bone tamp (ibt) through the cannula, it got stuck in the vertebra.
As the physician continued to pull the ibt, the distal portion of the ibt broke and was left in the patient.
There have been no patient symptoms or complications reported yet.
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