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Updated: Feb 4, 2026

3D Planning and Printing of Patient Specific Implants for Reconstruction of Bony Defects
Published on: August 4, 2020
Postmarket surveillance of 3D-printed implants for sacroiliac joint fusion
Daniel Cher1, Kendrick Wroe2, W Carlton Reckling3
1Clinical Affairs, SI-BONE, Inc., Santa Clara, CA, USA, dcher@si-bone.com.
Background:
Government regulations require postmarket surveillance for cleared/approved medical devices. Trend analysis of newly marketed devices may help to confirm device-related safety or uncover other device or procedure-related problems.
Methods:
Complaints related to the use of 3D-printed triangular titanium implants for sacroiliac joint (SIJ) fusion were compared with those of the prior machined version of the device manufactured with a titanium plasma spray (TPS) coating. Event rates were calculated either by dividing event counts by numbers of surgeries or, for late events, using Kaplan-Meier survival analysis.
Results:
Three types of complaints with nontrial frequencies were identified. Issues in instruments occurred at a low and constant rate (1.3%). Using Kaplan-Meier analysis, pain-related complaints occurred at a low and similar rate in both groups (<0.5%). The 1-year cumulative probability of surgical revision was low in both the 3D and machined versions of the device (1.5% for machined and 1% for 3D printed, P=0.0408 for difference). No implant breakages or migrations were identified in either group, and overall rates were similar to a previously published report.
Conclusion:
The 3D-printed version of triangular titanium implant was associated with complaint and adverse event rates similar to those for the prior machined version of the device.
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