Catalog Number 3505-4545 |
Device Problem
Disassembly (1168)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/22/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
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Event Description
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It was reported that the tulip of a pedicle screw was found to have detached after being installed in surgery.The screw was removed and replaced with an alternative screw to complete the procedure.There were no patient impacts reported in association with this event.
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Manufacturer Narrative
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Additional information: (ethnicity), (methods, results, and conclusions) - the polyaxial screw was returned for evaluation.The tulip head has disassembled from the shank.The cause of the disassembly is likely attributed to the deformation of the splines associated with final tightening and subsequent loosening of the rod and closure top within the tulip.A review of the dhr did not identify any issues which would have contributed to this event.
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Event Description
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It was reported that the tulip of a pedicle screw was found to have detached after being installed in surgery.The screw was removed and replaced with an alternative screw to complete the procedure.There were no patient impacts reported in association with this event.
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Search Alerts/Recalls
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