Catalog Number 48811240 |
Device Problems
Break (1069); Detachment Of Device Component (1104); Device Slipped (1584)
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Patient Problem
Pain (1994)
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Event Date 01/13/2016 |
Event Type
Injury
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Event Description
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It was reported that primary surgery was performed on (b)(6) 2013.Recently the patient reported neck pain, so x-ray showed a screw backing out and another one broken in left c7.During the removal, surgeon noticed fragments of the top of screws broken off and one of the spring bars was broken off.Patient seems fused.
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Manufacturer Narrative
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Method: visual inspection; device history review; complaint history review; risk assessment; results: the returned device was confirmed visually to have a fractured spring bar.Manufacturing files were reviewed and no anomalies were found.Conclusion: the plausible root cause of the reported event is not determined and multifactorial.
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Event Description
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It was reported that primary surgery was performed on (b)(6) 2013.Recently the patient reported neck pain, so x-ray showed a screw backing out and another one broken in left c7.During the removal, surgeon noticed fragments of the top of screws broken off and one of the spring bars was broken off.Patient seems fused.
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Search Alerts/Recalls
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