Catalog Number K09A |
Device Problem
Material Rupture (1546)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/03/2016 |
Event Type
malfunction
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Manufacturer Narrative
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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.
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Event Description
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It was reported that intra-op, balloons ruptured.It may have been because of spurs on patient's end-plate and posterior vertebral body.The contrast agent was not completely sucked out after the breakdown.Bone cement injection was not up to the planned effect (1.55cc/ every vertebral body).No patient complications were reported.No information regarding patient being allergic to the contrast media was reported.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Additional info: product analysis: the reported complaint of a balloon rupture was confirmed during product evaluation.Visual examination identified a radial tear was observed near the proximal peak of the balloon.This observation is consistent with rupture due to contact with bone splinters during instrument usage.Due to the ¿umbrella¿ effect of the radially cut ibt, the ibt was unable to be collapsed and removed from the stylus.The above observations are consistent with intraoperative instrument damage.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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