Catalog Number 6002-670-000 |
Device Problem
Image Orientation Incorrect (1305)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 04/26/2018 |
Event Type
malfunction
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Event Description
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It was reported that during a spine surgery at the user facility, the device was inaccurate.The surgeon performed a second scan using fluoroscopy in order to successfully complete the procedure.There was not a clinically significant delay and there were no adverse consequences.
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Manufacturer Narrative
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It was determined after receiving further clarification from the customer that this event was not a reportable event per cfr 21, part 803.The event was related to another manufacturers device.The customer has alerted the other manufacturer of the product malfunction.This supplemental is being filed to identify a mdr was not required for this event as the event was not related to a stryker device.
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Event Description
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It was reported that during a spine surgery at the user facility the device was inaccurate.The surgeon performed a second scan using fluoroscopy in order to successfully complete the procedure.There was not a clinically significant delay and there were no adverse consequences.
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Search Alerts/Recalls
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