Twelve-year Retrospective Analysis of Commercially Available Corpectomy Devices from the Food and Drug Administration’s Manufacturer and User Facility Device Experience Database

Introduction: The Manufacturer and User Facility Database (MAUDE) provided by the Food and Drug Administration
(FDA) organization is a regulatory tool for post market surveillance providing vital information regarding defects and adverse events pertaining to commercially available devices. Corpectomies devices have evolved over the years to the current expandable titanium cage commonly used. We present an overview of the adverse events of corpectomies reported in the MAUDE database.

Methods: Retrospective data was collected on the MAUDE database between January 1, 2010 to October 18, 2022. Corpectomy cages included those manufactured by Medtronic, Globus, Depuy Synthes. Reports that were

Results: Overall, 348 adverse events met the inclusion criteria. Corpectomy devices (348) included Medtronic 158 (T2 Stratosphere), Globus Medical - 42 (Fortify - 28, XPAND – 14), Stryker – 83(VLIFT), Depuy Synthes – 60(XRL) and Ulrich Medical –5 (Solidity). Corpectomy related adverse events were grouped into 23 categories .Corpectomy breakage (18%) was the most widely reported adverse event followed by migration/expulsion of device (16%). Fracture (10%) altered mechanics (10%), activation failure (7%) and collapse (7%) were the other prominent device related complications. Of the reported events, patients commonly did not have any clinical signs/symptoms (72%) while 12% reports had inadequate patient related information. Other patient related complications included bone fracture, implant failure, hemorrhage, peripheral nerve injury, pain, post-operative wound infection, and tissue damage. Corpectomy collapse was the most common device complication reported from Fortify (15/28) and Xpand (4/14), while the most common complication for VLIFT was corpectomy break (35/83). T2 Stratosphere reported migration or expulsion of device (45/158) and XRL reported mechanical complications (13/60) as the most common complication.

Conclusion : MAUDE database serves as a valuable post market surveillance tool. Valuable information regarding device related complications can aid surgeons in clinical decision making.