Postmarket surveillance of 3D-printed implants for sacroiliac joint fusion

Abstract

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.

Keywords:

• permanent implants
• quality system
• complaint analysis
• adverse events
• postmarket surveillance
• sacroiliac joint fusion

Disclosure

All authors are employees of SI-BONE, Inc., which manufactures the implants described herein. The authors report no other conflicts of interest in this work.