Catalog Number 48132601 |
Device Problems
Break (1069); Fracture (1260); Detachment of Device or Device Component (2907)
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Patient Problems
Dyspnea (1816); Fall (1848); Pain (1994); Injury (2348); Ambulation Difficulties (2544)
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Event Date 05/16/2018 |
Event Type
Injury
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Event Description
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It was reported that the rod broke in half and screws came out post-operatively.Patient reportedly had fall in (b)(6) of 2017 in which she tripped over a chair and fell on their knees.The patient was in pain, couldn't walk, trouble breathing and couldn't lift arm.The patient underwent revision surgery on (b)(6) 2018 to replace hardware.
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Manufacturer Narrative
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Method: surgical notes review, x-ray image review, nc/capa history review, labelling review, risk assessment.Result: the reported event was confirmed upon review of surgical notes and x-ray image.Products were not returned for evaluation and no lot# was provided therefore manufacturing records review and complaint history review could not be performed.Patient was reported to have had a fall in thanksgiving of 2017 in which she tripped over a chair and fell on knees.Conclusion: the root cause of the reported event could not be determined conclusively but it is likely that the patient fall (a few months ago) may have contributed to the event - perhaps a crack in the rod at the time of fall which may have lead to fracture due to fatigue over time.
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Event Description
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It was reported that the rod broke in half and screws came out post-operatively.Patient reportedly had fall in thanksgiving of 2017 in which she tripped over a chair and fell on their knees.The patient was in pain, couldn't walk, trouble breathing and couldn't lift arm.The patient underwent revision surgery on (b)(6) 2018 to replace hardware.
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Search Alerts/Recalls
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