Catalog Number 48651120 |
Device Problem
Device Inoperable (1663)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/01/2014 |
Event Type
malfunction
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Event Description
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It was reported that plate remaining at c5-6, using reflex hybrid to fuse c6-7.The surgeon trying to use same holes realized that the ring on plates failed.There was a delay about 5 minutes.
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Manufacturer Narrative
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Method: device history review; complaint history review; results: the stryker rep confirmed that this was a revision surgery of a competitor's plate to extend fusion to the c6-c7 vertebrae.The rep reported that the surgeon initially used the existing holes from the competitor's plate, however this is where the screws deformed the locking ring on the stryker plate due to over-angulation (the recommended angulation is outlined in the surgical technique) of the screws in the existing holes.A new plate with new holes was successfully implanted.Conclusion: the returned reflex-hybrid 1 level acp was confirmed to have a deformed locking ring.Manufacturing records for this product were reviewed and no incidents were found.This was the first reported event for this lot.No new harms/severities were reported.
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Event Description
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It was reported that plate remaining at c5-6, using reflex hybrid to fuse c6-7.The surgeon trying to use same holes realized that the ring on plates failed.There was a delay about 5 minutes.
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Search Alerts/Recalls
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