(b)(4).
Coroent lc, 8x11x25 8 degrees reportedly was placed during a l4-l5 tlif on friday august 31, 2012.
Later in the evening the ct scan revealed that the implant was placed posterior into the vertebral canal with potentially compromising the vertebral canal.
Ct scans were not made available to nuvasive.
The surgeon brought the pt back the following day and decided to remove the implant and surgically widened the decompression and mitigated the need for a coroent implant.
There was no pt injury and no related symptoms as a result of the placement or removal of this implant.
The tlif surgical technique relies on identifying anatomical landmarks for successful placement of a coroent lc implant.
It appears the surgeon was unsuccessful in his surgical technique and was unable to identify the final placement before concluding treatment of the pt.
This resulted in the need for revision surgery the following day.
There was no alleged product deficiency reported with this event.
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