Catalog Number 55410007545 |
Device Problem
Scratched Material (3020)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/29/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Product was not returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the patient underwent deformation correction surgery at th4-l5.Intra-op, the set screw overturned, which destroyed the fixed-angle screw.The damaged screw was then explanted and replaced with a multi-axial screw.The set screw overturned because the surgeon did not use a counter-torque instrument.There were no patient symptoms or complications as a result of this event.
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Manufacturer Narrative
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Product analysis: after visual and optical examination and functional testing, it does not appear to be any damage nor does it indicate any functional issues with the screw.Unable to replicate customer concern.Unable to determine root cause of the foregoing event from the available information.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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