Catalog Number 3505-5540 |
Device Problem
Disassembly (1168)
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Patient Problem
No Code Available (3191)
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Event Date 05/24/2017 |
Event Type
Injury
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Manufacturer Narrative
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The device was scrapped by the hospital, so it is not available for evaluation.A review of the manufacturing records did not identify any issues which would have contributed to this event.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 3012447612-2017-00216.
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Event Description
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It was reported that the tulips of two pedicle screws disassembled during surgery.After placing the closure tops, the surgeon decided to remove the closure tops so that the rod could be further contoured.After the rod was removed, the surgeon found two of the tulips had disassembled from their screw shafts and proceeded to remove the screw shafts which led to a delay of 100 minutes.Two additional screws were installed to complete the procedure.This is report one of two for this event.
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Manufacturer Narrative
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Although the device was not returned for evaluation, a photo was provided and was used for evaluation purposes.It appears that at least one of the three splines on the screw shaft has been deformed, which allows the screw tulip to disassemble from the screw shaft.The cause is likely attributed to tightening and then loosening the closure top within the screw tulip.
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Search Alerts/Recalls
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