The First 18 Months Following Food and Drug Administration Approval of Lumbar Total Disc Replacement in the United States: Reported Adverse Events Outside an Investigational Device Exemption Study Environment

Article Figures & Data

Table 1

Postapproval Key Adverse Events and Overall Reoperation Rates Compared With the Investigational Device Exemption (IDE) Study

	6 mos Post-FDA Approval (N = 1714)	12 mos Post-FDA Approval (N = 4055) (Cumulative)	18 mos Post-FDA Approval (N = 5575) (Cumulative)	IDE Study (N = 276)
Adverse event, n (%)
Anterior migration with reoperation	1 (0.06)	28 (0.69)	36 (0.65)	3 (1.09)
Sizing/malposition with reoperation	2 (0.12)	18 (0.44)	20 (0.36)	1 (0.36)
Bone fragment with reoperation	0	2 (0.05)	2 (0.04)	0
End plate fracture	1 (0.06)	6 (0.15)	6 (0.11)	0
Posterior element fracture with reoperation	1 (0.06)	12 (0.30)	17 (0.30)	5 (1.81)
Subsidence with reoperation	1 (0.06)	5 (0.12)	11 (0.20)	0
Posterior migration with reoperation	1 (0.06)	2 (0.05)	4 (0.07)	0
Major vascular injury requiring transfusion	2 (0.12)	13 (0.32)	13 (0.23)	1 (0.36)
Major neurological^a	0	5 (0.12)	5 (0.09)	13 (4.71)
Deep wound infection	0	2 (0.05)	2 (0.04)	0
Death	1 (0.06)	2 (0.05)	3 (0.05)	1 (0.36)
Total	10 (0.58)	95 (2.34)	119 (2.13)	24 (8.70)
Overall reoperations, n (%)
Reoperations, 360-degree revisions, and off-label reoperations	6 (0.35)	67 (1.65)	90 (1.61)	15 (5.43)