Adverse events
lower-back pain, postoperative radiculopathy, hyposthesia, lower back pain, Hypoesthesia
ADVERSE EVENT, ADVERSE EVENT
Adverse events (AEs) were reported and characterized by relatedness and severity. Three AEs were considered related to the graft/surgical procedure. A single serious AE (postoperative radiculopathy) was reported as definitely related to the bone graft. Surgical exploration revealed extrusion of the graft material from the interbody. This subject demonstrated successful fusion at 12 months. Two additional AEs reported as probably related to the surgical procedure included hyposthesia and increased lower back pain. Hypoesthesia, which resulted in numbness/loss of sensation in the left lower extremity, was categorized as non-serious and treated with unspecified medication. Increased lower-back pain resulted in the subject undergoing a two-level laminectomy and fusion. Demographics, baseline characteristics, and risk factors for these three subjects are presented in Table 
Demographics and Baseline Variables for Subjects with Adverse Events Related to the Graft or Surgical Procedure.