Model Number 9734716 |
Device Problem
Output Problem (3005)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/09/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluation has not been done at the time of submitting this report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information regarding a navigation system used during a sacroiliac and thoracolumbar procedure.It was reported that the spinous process clamp moved.They were working on the last level, l5, and noticed that the clamp had moved.They checked their accuracy and decided to finish the case with a c-arm.Troubleshooting was done by the clinical specialist (cs) that was onsite and there were no issues with the clamp remaining engaged.It was believed that it was attached to soft tissue that allowed it to shift.There was a procedure delay of less than one hour and no impact to the patient.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received.It was reported that the clamp became loose prior to putting the last screw in.After the case the clamp was checked and passed the checkout.
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Search Alerts/Recalls
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