Medicolegal corner (spine): Contraindicated use of DuraSeal in anterior cervical spine led to quadriplegia

Abstract

Background: The package insert for DuraSeal (Integra LifeSciences, Princeton NJ) states it is Contraindicated for use in the anterior cervical spine (confined space): “Do not apply DuraSeal® hydrogel to confined bony structures where nerves are present since neural compression may result due to hydrogel swelling (…up to 12% of its size in any direction).” Further, it should not be used to treat massive unrepaired cerebrospinal fluid (CSF) leaks in any location; “…(it) is indicated as an adjunct to sutured dural repair during spine surgery to provide watertight closure,” but it is not to be used “...for a gap greater than 2 mm….” Methods: A spinal surgeon interpreted a geriatric patient’s MR as showing severe C3-C4 to C5-C6 anterior cord compression due to disc disease/spondylosis. However, he never reviewed the CT report/images that documented marked ossification of the posterior longitudinal ligament (OPLL) with multiple signs of dural penetrance. Results: The anterior C4, C5 corpectomy, and C3-C6 strut fusion/plating resulted in a massive, irreparable cerebrospinal fluid (CSF) leak. Despite the contraindications, the surgeon mistakenly applied DuraSeal which caused the patient’s postoperative quadriplegia (i.e., as documented on the delayed postoperative MR scan). Following a secondary surgery consisting of a laminectomy/posterior fusion, the patient was still quadriplegic. Further, as he requested no postoperative MR scan and performed no subsequent corrective surgery (i.e., anterior removal of DuraSeal), the patient remained permanently quadriplegic. Conclusion: DuraSeal is directly contraindicated for use in the anterior cervical spine, with/without a CSF leak. Here, utilizing DuraSeal for anterior cervical OPLL surgery resulted in permanent quadriplegia, and was below the standard of care.