Model Number 9736060 |
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 01/14/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information was unavailable from the site.Device manufacturing date, unknown.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 guidance system being used during a spinal procedure.It was reported that during a revision case where they were adding l2 and l5 to an existing construct, there were issues tracking the blue and black navlocks and the robotic reference frame.They were tracking intermittently.The representative had the spheres replaced and verified they were snapped into place.There was no line of site issues.The representative moved or lights away as well.When the instrument was tracked it was showing up in the middle of the near/far tracking range under tracking details.The representative checked the geometry error and it was resting at.35 -.45 when the instrument was facing the camera straight on.No patient harm was reported.
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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 received from a manufacturer representative reported that they did determine that the problem was not with the reference frame or any of the navlocks but rather was caused by interference from the surgeons camera headlight.When the surgeon stared at the surgeon tablet, they found that the instruments and reference frame would disappear from the tracking view, however, when he looked away, they would reappear.The problem only occurred when using that particular headlight.Since the issue was determined to not reside with the devices, they have not been returned for analysis.
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Manufacturer Narrative
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Additional information: patient information updated.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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