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 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.Reference reports 3012447612-2017-00504 thru 3012447612-2017-00506.
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Event Description
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It was reported that three pedicle screws disassembled during surgery.While a previously installed construct was being loosened, the tulips detached from the threaded shafts.They were removed and replaced with alternative screws.There were no reports of patient injury associated with this event.This is report one of three for this event.
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Manufacturer Narrative
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The returned screw was examined.The screw components were found to have disassembled due to deformation on the swivel rings, which was caused when the screw was locked into position, then unlocked and repositioned during the procedure.A review of the manufacturing records did not identify any issues which would have contributed to this event.
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Search Alerts/Recalls
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