Model Number S7 |
Device Problem
Imprecision (1307)
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Patient Problems
Injury (2348); Iatrogenic Source (2498)
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Event Date 12/19/2017 |
Event Type
Injury
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Manufacturer Narrative
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A medtronic representative went to the site to test the equipment.The representative was unable to replicate the reported issue.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.
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Event Description
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A site representative reported that, while in an open transforaminal lumbar interbody fusion (tlif), an imprecision was observed and it was noted that the screw was placed inaccurately.It was reported that a lumbar screw was placed on the left side of the pedicle inaccurately by about 1-2 millimeters.It was noted that the screw was removed and repositioned.There was a reported delay to the procedure of fifteen minutes due to this issue.No additional information was provided.
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Manufacturer Narrative
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A software analysis was initiated.However, the software evaluation found that a probable cause was unable to be determined.
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Search Alerts/Recalls
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