Catalog Number 3505-6550 |
Device Problem
Disassembly (1168)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/22/2017 |
Event Type
Injury
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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 report 3004485144-2017-00158.
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Event Description
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It was reported that a closure top and pedicle screw were damaged during surgery.The threads of the closure top were damaged and sheared during final tightening.The closure top and pedicle screw were removed.During review of the removed pedicle screw on the back table, it was noted the tulip was detached from the screw shaft.A new pedicle screw and closure top were used to complete the procedure.There were no reports of patient injury associated with this event.This is report two of two for this event.
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Manufacturer Narrative
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Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
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Manufacturer Narrative
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The returned device was evaluated.The tulip was confirmed to have disassembled from the shaft.The cause is attributed to tightening and loosening of the rod and closure top within the tulip.A review of the manufacturing records did not identify any issues which would have contributed to this event.The labeling was reviewed and found to contain sufficient instructions regarding device usage.
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Search Alerts/Recalls
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