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

Introduction: The Manufacturer and User Facility Device Experience 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. Dural grafts have been in use to surgically close dura mater post durotomy. We present an analysis of current commercial dural grafts as reported in the MAUDE database.

Methods: Retrospective data was collected on the MAUDE database between January 1, 2010 to October 18, 2022. Data on incident, location, device related complications and patient related complications were collected. Duplicates and non-dural graft related devices were excluded from the study

Results: Overall, 366 adverse events were reported to the MAUDE database. Company associated breakup included Integra Lifesciences 277(76%), Medtronic 62(17%), Synovis surgical innovations 20(6%), Acera Surgical 4( < 1%) and Natus Neuro 3( < 1%). Individual grafts from Integra Lifesciences included Duragen 142(39%), Duragen Plus 34(9%), Duragen Suturable Regeneration Template 23 (6%), Unknown product ID (18%) and Duragen RM Regeneration matrix (3%). Predominant number of device related complications did not have appropriate device or use identification 249(68%). Of the identifiable complications, primary adverse event was material integrity 40(11%) followed by fluid leak 19(6%) and mechanical complications 15(4%). Other reported events included contamination, breaching expiration period, improper procedure, patient device incompatibility etc. Patient related complications primarily involved cerebrospinal fluid leak 104(28%), post-operative infection 35 (10%), injury 32(9%), Febrile reaction 29(8%), bacterial infection 14 (4%) among others. Primary patient related complication for Duragen, Duragen Plus, Duragen Suturable Regeneration Template, Duragen Unknown product ID, Cerafix Dural was cerebrospinal fluid leak. Integra Lifesciences reported 90(25%) CSF leaks followed by Hypersensitivity/allergic reactions 31(9%.

Conclusion : MAUDE database is a valuable tool for post market surveillance yielding product specific information that can aid in surgical decision making.