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Model Number 6143.1001 |
Device Problem
Malposition of Device (2616)
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Patient Problem
Unspecified Tissue Injury (4559)
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Event Date 07/21/2021 |
Event Type
Injury
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Manufacturer Narrative
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Investigation revealed no system malfunction was found.The software correctly detected the warning and alerted the user of excessive forces on the load cell during bone work, as a result of skiving forces detected while a tool was inserted in the end effector.Additional information provided that the patient moved on the table during initial screw placement, affecting navigation integrity and misplacement of screws.Evaluation of the case and case logs found that the cause of the reported issue was traced to user technique.
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Event Description
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It was reported that a screw was misplaced at the left l5 due to patient movement resulting in a dural tear, which was repaired intra-operatively.
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Search Alerts/Recalls
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