Catalog Number 3505-6550 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problems
Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
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Event Date 12/11/2017 |
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.The lot number is unknown; therefore the device history records are unable to be reviewed.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.(b)(4).
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Event Description
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It was reported that the threads of a closure top were damaged during installation into the mating pedicle screw in surgery.The closure top needed to be cut to be removed and the pedicle screw was also removed.An alternative screw and closure top were used to complete the procedure.There was a surgical delay greater than 30 minutes and the patient retained a device fragment.No further patient impact was reported.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 pedicle screw was evaluated.The tulip threads were found damaged in a manner consistent with cross-threading.The tulip was disassembled from the shaft due to deformation of the shaft splines and swivel ring in a manner consistent with locking and subsequent unlocking of the screw with the mating rod and closure top.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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