Model Number 8900-100-000 |
Device Problems
Display or Visual Feedback Problem (1184); Incorrect Measurement (1383); Improper or Incorrect Procedure or Method (2017)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/03/2023 |
Event Type
malfunction
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Event Description
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Per the customer, auto-segmentation was not available after the airo scan as the licensing for it was not implemented.While navigating screws, there appeared to be movement on the screen/images without anything touching the screen.After a confirmation spin with the airo, 2 out of 8 screws were angled more cranial despite following our preplanned trajectory.The two screws were revised after the confirmation scan.The procedure was completed successfully with the same device without a clinically significant delay; no medical intervention or adverse consequences were reported.
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Event Description
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Per the customer, auto-segmentation was not available after the airo scan as the licensing for it was not implemented.While navigating screws, there appeared to be movement on the screen/images without anything touching the screen.After a confirmation spin with the airo, 2 out of 8 screws were angled more cranial despite following our preplanned trajectory.The two screws were revised after the confirmation scan.The procedure was completed successfully with the same device without a clinically significant delay; no medical intervention or adverse consequences were reported.
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Manufacturer Narrative
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Follow-up report submitted to document the device was not available for evaluation.No product return.
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Search Alerts/Recalls
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