Model Number N/A |
Device Problem
Disassembly (1168)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/03/2016 |
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.This is report one of four for this event.Reference reports 3004485144-2016-00361 thru 3004485144-2016-00364.
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Event Description
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It was reported that a pedicle screw disassembled while trying to further install it into the pedicle after initial placement.Additionally, three closure tops fractured during final tightening within the same procedure.The three closure tops and pedicle screw were replaced.There were no reports of patient harm associated with this event, however the surgery was delayed by 45 minutes.
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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 screw was evaluated.The tulip head had disassembled from the screw shaft; the complaint is confirmed.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, including the instruments which should be used for adjustments to the screw's position.However, these instructions were not followed and the complainant has been notified.
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Search Alerts/Recalls
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