Model Number BI-700-00027-120 |
Device Problems
Imprecision (1307); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/09/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Patient identifier not available from the site.No parts have been received by the manufacturer for evaluation.
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Event Description
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Medtronic received information regarding an imaging device being used for a spinal fusion procedure.It was reported that the system had imprecision by 1mm with the left side of the imaging system.The manufacturing representative (rep) re calibrated the system and confirmed they were immediately imprecise.The site took into account the amount of imprecision and proceeded.There was no reported impact on patient outcome.There was a reported delay to the procedure of less than 1 hour due to this issue.No further information was provided.
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Manufacturer Narrative
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Patient identifier not available from the site.No parts have been received by the manufacturer for evaluation.
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Event Description
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Medtronic received information regarding a navigation instrument being used for a spinal fusion procedure.It was reported that the short clamp does not close.The redesign that was made it difficult to close the clamp.The threads had been removed at the top and if it is opened too wide, the threading in the screw is too far away from the threading in the screw hole.Thus, the clamp would not work on too thick of spinous process.There was no reported impact on patient outcome.There was no reported delay to the procedure due to this issue.No further information was provided.
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Manufacturer Narrative
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Added in the event summary, how the issue was resolved.
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Event Description
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Medtronic received information regarding a navigation instrument being used intra-operatively for a spinal fusion procedure.It was reported that the short clamp does not close.The redesign made it difficult to close the clamp.The threads had been removed at the top and, if it is opened too wide, the threading in the screw is too far away from the threading in the screw hole.Thus, the clamp would not work on too thick of spinous process.There was no reported impact on patient outcome.It was further reported that the issue was resolved by informing the customer about the deficiency in the product and how to work around it.There was no reported delay to the procedure due to this issue.No further information was provided.
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Manufacturer Narrative
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Fda codes were updated to reflect current coding guidelines.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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