Model Number N/A |
Device Problems
Disassembly (1168); Device-Device Incompatibility (2919)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 09/21/2016 |
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.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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Event Description
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It was reported that during a pathfinder nxt case, the surgeon attempted to insert a 7.5 x 55mm screw through a k-wire into the pedicle.However, half way into the vertebral body, the k-wire became stuck in the cannulation of the poly screw and there was difficulty in removing the k-wire.So the surgeon decided to back out the entire screw (along with the k-wire stuck in the middle cannulation).As he backed the screw out of the vertebral body and pedicle, he found out that the pedicle screw head and shank has become dislocated.To finish the surgery, he inserted a new k-wire and a new 7.5 x 55 mm screw.This was done successfully.
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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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Additional information was received from the reporter, who stated the k-wire used in this event came from another set.The returned screw was evaluated.The tulip was found disassembled form the shaft and a k-wire was found stuck within the screw shaft.The k-wire was found to be a product which is not distributed as part of or intended to be used with the pathfinder nxt system.As such, the dimensions of the k-wire used do not meet those of the pathfinder nxt system and caused it to be lodged within the pedicle screw.The disassembly is likely related to the screw being partially installed, removed, and manipulated to remove the k-wire.A review of the manufacturing records did not indicate any issues which may have contributed to this event.The labeling was reviewed and found to contain indications for device usage and warnings against reuse of implants.
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Search Alerts/Recalls
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