The two explanted pedicle screws are (model 7715-6545/lot l516305; model 7715-7540/lot lx-2270).
Method: the spinous process fusion plate was not returned because it was removed intact with the spinous process.
An evaluation could not be performed.
Visual examination of the returned pedicle screws did not identify a failure and none was reported.
Based on a review of the operative notes the post-operative diagnosis was the same, indicating pseudoarthrosis.
The surgeon placed a second interbody cage; the first cage from the index surgery was left in place.
Autograft and autologous morsellized bone, and bmp was placed in the disk space.
The l5-s1 was re-fixated with bilateral pedicle screws.
A patient underwent follow-up lumbar fusion surgery.
Pre-operative diagnosis indicated pseudoarthrosis l5-s1, bilateral proximal lumbar radiculopathy, and lumbago.
The original surgery was performed on (b)(6) 2011 to address discogenic back pain, lumbago, and right lower extremity and radiculopathy.
The follow-up surgery required removal of a spinous process fusion plate and removal of unilateral pedicle screws.
A laminectomy, foraminotomies, and further decompression of l5-s1 was performed.
Operative notes do not indicate a malfunction of the implants and none was alleged.