Catalog Number 48551044 |
Device Problems
Disconnection (1171); Fracture (1260)
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Patient Problems
Pain (1994); Injury (2348)
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Event Date 10/25/2018 |
Event Type
Injury
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Event Description
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It was reported that the two tulips on plate have disconnected from plate post-operatively.Revision surgery will be required.The patient was experiencing pain.
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Manufacturer Narrative
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Visual inspection of the plate identified a small amount of intact fracture surfaces where the tulip pins fractured, an approximate origin was able to be established.Materials analysis was performed in a similar complaint and found that "each tulip pin have ductally fractured in a mode of reverse bending.The elemental constituents were consistent with what is specified on the print.No material or manufacturing defects were found¿.Product history and complaint history review on the reported lot was without incident and no prior complaints.It was reported that the patient was revised using a competitor product.The surgeon did not provide any additional information on this case.No complications in the surgery and the patient's pathology was unknown.The patient did not fuse, which is the probable root cause of the tulip separation.According to the ifu "these implants are temporary internal fixation devices designed to stabilize the operative site during the normal healing process.After healing occurs, these devices serve no functional purpose and can be removed".
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Event Description
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It was reported that the two tulips on plate have disconnected from plate post-operatively.Revision surgery will be required.The patient was experiencing pain.
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Manufacturer Narrative
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Method: x-ray image review, nc/capa history review, labelling review, risk assessment.Result: the reported event was confirmed upon x-ray image review.The device was not returned, therefore the device evaluation could not be performed.Manufacturing files were not reviewed due to no parts or lot provided.Conclusion: the possible root causes include: improper construct, set screws not tightened correctly.Excessive load due to unstable construct.Excessive load due to patient anatomy/pathology.Patient performs strenuous post-op activities.Surgeon applying too much torque to seat the screw head.
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Event Description
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It was reported that the two tulips on plate have disconnected from plate post-operatively.Revision surgery will be required.The patient was experiencing pain.
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Search Alerts/Recalls
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