Catalog Number K09A |
Device Problem
Deflation Problem (1149)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/21/2018 |
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.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the patient presented with primary osteoporosis and compression fracture at t12.Intra-op, while performing the surgery, ibt balloon on the right side was failed to deflect using the handle.Although by turning the handle counterclockwise the situation was same.No fragments remained in the patient.No patient complications were reported.
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Manufacturer Narrative
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Additional information: the kit was analyzed and it was found that there was a small cut in the tubing of the syringe.If this cut was there at the time of deflation it would have kept the balloon from deflating properly.The cut could not have been there at the time of inflation as the tubing would have had a noticeable leak.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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