Catalog Number 3505-7550 |
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.
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Event Description
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It was reported that the tulip of a pedicle screw detached from the screw shaft during surgery.The surgeon loosened the screw from the inserter to change the screw's trajectory.The tulip detached after the screw was retightened to the inserter and the screw was further installed.The screw shaft was successfully removed from the wound.There were no reports of patient injury associated with this event.
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Manufacturer Narrative
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The returned screw was evaluated.The tulip has disassembled from the screw shaft due to deformation on the swivel ring and shaft splines.It is likely that while tightening the polyaxial screw, a very high force was applied to the screw head, causing the material on the ring to push back and the splines to deform.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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