Background context: Allograft bone is commonly used in various spinal surgeries. The large amount of recalled allograft tissue, particularly in recent years, has increased concerns regarding the safety of allograft bone for spinal surgery. An analysis of allograft recall and its safety in spinal surgery has not been reported previously.
Purpose: To determine 1) the number and types of allograft recall and the reasons for recall, 2) the types of disease transmission to spine patients, and 3) assess the safety of allograft bone in spinal surgery.
Study design/setting: Retrospective review.
Methods: A retrospective review of all Food and Drug Administration (FDA) data from 1994 to June 2007 was reviewed to determine the amount and types of recalled allograft tissue. The literature and data from the Center for Disease Control were reviewed to determine the number and types of disease transmissions from allograft bone that have occurred to spine surgery patients during the study period.
Results: There were 59,476 musculoskeletal allograft tissue specimens recalled by FDA during the study period, which accounts for 96.5% of all allograft tissue recalled in the United States. Improper donor evaluation, contamination, and recipient infections are the main reasons for allograft recall. There has been one case of human immunodeficiency virus infection transmission to a spine surgery patient in 1988. This is the only reported case of viral transmission. There are no reports of bacterial disease transmission from the use of allograft bone to spine surgery patients.
Conclusions: The precise number of allografts used in spine surgery annually and the precise incidence of disease transmission to spine surgery patients linked to the use of allograft tissue is unknown. Musculoskeletal allograft tissue accounts for the majority of recalled tissue by FDA. Despite the large number of allograft recalls in this country, there is only one documented case in the literature of disease transmission to a spine surgery patient. There appears to be no overt risk associated with the use of allograft bone in spine surgery. However, as discussed in this article, there are certain aspects regarding the use of allograft bone that should be considered.