Model Number 9735665 |
Device Problem
Imprecision (1307)
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Patient Problems
Spinal Column Injury (2081); Tissue Damage (2104)
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Event Date 11/09/2018 |
Event Type
Injury
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Manufacturer Narrative
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A medtronic representative went to the site to test the equipment.Testing revealed that the system performed as intended, no hardware parts were replaced and there was no failure detected.The system then passed the system checkout and was found to be fully functional.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 device being used for a sacroiliac and thoracolumbar procedure.The issue occurred intraoperatively during the navigate task and delayed the surgery by less than one hour.It was reported that in a minimally invasive case today the surgeon placed screws approximately 10 mm off from navigated placement.The site respun the patient and had to replace all of the screws.The site typically has the camera at the foot of the bed and places screws moving towards the reference frame, but for this case they had the camera at the head of the bed and placed their 6 screws (l3 to s1) moving away from the reference frame (attached at l3).The manufacturer representative informed site that reference frame movement was likely the cause.The surgery was completed with navigation.
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Manufacturer Narrative
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Software investigation found that the reported event was related to a software issue.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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The event reported in this 3500a also represents a potential accidental radiation occurrence (aro) per 21 cfr 1002.20(a).Per 21 cfr 1002.20(c), this event is also being reported under part 803.Supplemental aro information is as follows: 3d dose absorbed (patient): 11.21msv (negligible) 1 - patient total number of people in or unknown.(b)(6).If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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A software investigation analysis was initiated to determine the probable cause of the issue through known anomaly determination.The software investigation found that the reported event was related to a software issue.This issue was documented in a medtronic navigation software anomaly tracking database.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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