Catalog Number 48551080 |
Device Problems
Device Operates Differently Than Expected (2913); Naturally Worn (2988)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/16/2015 |
Event Type
malfunction
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Event Description
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It was reported that during surgery, it was found that the hex of connector cap was worn.So the cap was not able to loosen with driver before using.The surgeon used other smaller connector.The second connector was attached to rod in patient, but its cap was not able to be tightened.The driver did not fit the hex of the cap.After that the surgeon exchanged only the cap to a cap from other connector.
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Manufacturer Narrative
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Method: device functional inspection.Device history review.Results: device was confirmed to be fully functional.The returned connector was found to be able to place and tighten the blocker and remove the blocker without incident.Manufacturing were reviewed and no anomalies found.Conclusion: no product issue was found.
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Event Description
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It was reported that during surgery, it was found that the hex of connector cap was worn.So the cap was not able to loosen with driver before using.The surgeon used other smaller connector.The second connector was attached to rod in patient, but its cap was not able to be tightened.The driver did not fit the hex of the cap.After that the surgeon exchanged only the cap to a cap from other connector.
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Search Alerts/Recalls
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