Model Number 6000-999-005 |
Device Problems
Fracture (1260); Detachment of Device or Device Component (2907)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/29/2019 |
Event Type
malfunction
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Event Description
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It was reported the device was in pieces during a routine maintenance visit this poses the risk of a small component being lost in the surgical site.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing at the user facility, there was no patient involvement and no delay to a surgical procedure.
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Event Description
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It was reported the device was in pieces during a routine maintenance visit this poses the risk of a small component being lost in the surgical site.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing at the user facility, there was no patient involvement and no delay to a surgical procedure.
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Manufacturer Narrative
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Device evaluation: follow-up report submitted to document device evaluation results.H3 other text : discarded.
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Search Alerts/Recalls
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