Model Number N/A |
Device Problem
Disassembly (1168)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/07/2016 |
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.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.This is report one of seven for this event.Reference 3004485144-2016-00349 - 3004485144-2016-00355.
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Event Description
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It was reported that during surgery while trying to install the closure top at the top of the construct at t10, the surgeon cross-threaded six closure tops.He then decided to remove the pedicle screw at that level.However, during removal, the tulip disassembled from the pedicle screw.He then installed a new pedicle screw and the closure top was installed successfully into this screw.There was no reported injury to the patient during this event.
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Manufacturer Narrative
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Additional information was received that stated that part information initially provided was incorrect.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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Manufacturer Narrative
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The returned device was evaluated.The tulip was found disassembled from the screw shaft and the screw head insert had been deformed.The complaint is confirmed.The disassembled screw head and the distorted screw head insert were likely a result of the screw removal.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 instructions regarding proper device usage.
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Search Alerts/Recalls
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