Catalog Number 0607687000 |
Device Problem
Disassembly (1168)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/15/2014 |
Event Type
malfunction
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Event Description
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It was reported that during a vertebroplasty, the valve that hooks onto the needle of the autoplex system broke off.It was reported that nothing fell into the surgical site and that the procedure was completed successfully utilizing back-up equipment.No clinically significant delay, no medical intervention and no adverse consequences were reported with this event.
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Event Description
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It was reported that during a vertebroplasty the valve that hooks onto the needle of the autoplex system broke off.It was reported that nothing fell into the surgical site and that the procedure was completed successfully utilizing back-up equipment.No clinically significant delay, no medical intervention and no adverse consequences were reported with this event.
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Manufacturer Narrative
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Upon visual inspection, the extension tube assembly was found to be broken at its distal end.The device was discarded by the manufacturer.
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Manufacturer Narrative
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A follow up report will be filed after the quality investigation has been completed.
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Search Alerts/Recalls
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