Model Number 6143.1001 |
Device Problem
Use of Device Problem (1670)
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Patient Problem
Insufficient Information (4580)
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Event Date 12/15/2021 |
Event Type
Injury
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Manufacturer Narrative
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Investigation revealed there was no system malfunction.Additional information provided that the user applied pressure to the screw heads of s1 during fluoroscopic image acquisition.This can cause a change in the patient anatomy in relation to the dynamic reference base, and lead to navigation integrity issues.The software correctly detected excessive forces and alerted the user.The software prompts the user to perform an anatomical landmark check before proceeding with navigation.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 patient experienced adverse effects following surgery where a screw was misplaced intra-operatively.
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Manufacturer Narrative
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Investigation revealed there was no system malfunction.Additional information provided that the user applied pressure to the screw heads of s1 during fluoroscopic image acquisition.This can cause a change in the patient anatomy in relation to the dynamic reference base, and lead to navigation integrity issues.The software correctly detected excessive forces and alerted the user.The software prompts the user to perform an anatomical landmark check before proceeding with navigation.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 patient experienced adverse effects following surgery where a screw was misplaced intra-operatively.
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Search Alerts/Recalls
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