Model Number 03821645 |
Device Problems
Difficult to Insert (1316); Device Operates Differently Than Expected (2913); Material Deformation (2976)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Information (3190)
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Event Date 04/28/2017 |
Event Type
Injury
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Event Description
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It was reported that; when doctor used the spreader to distract the screws ,he found the reduction polyaxial screws's head fixed and cannot move any more.The doctor according to the fixed screw way using the screw.However, caused great difficulties of installation rod, operation time delay.
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Manufacturer Narrative
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Method: device history review, complaint history review, risk assessment; result: manufacturing records were reviewed for the corresponding lot and no relevant issues were identified.The device.Has not been returned as it remains implanted in the patient and is unavailable for inspection conclusion: the plausible root cause of the event cannot be determined as the device remains implanted and is unavilable for inspection.
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Event Description
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It was reported that; when doctor used the spreader to distract the srcews, he found the reduction polyaxial screws's head fixed and cannot move any more.The doctor according to the fixed screw way using the screw.However, caused great difficulties of installation rod, operation time delay.
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Search Alerts/Recalls
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