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. 2018 Sep 28:11:337-343.
doi: 10.2147/MDER.S180958. eCollection 2018.

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

Daniel Cher  1 , Kendrick Wroe  2 , W Carlton Reckling  3 , Scott Yerby  4
Affiliations

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

Daniel Cher et al. Med Devices (Auckl). .

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: adverse events; complaint analysis; permanent implants; postmarket surveillance; quality system; sacroiliac joint fusion.

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Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Top: triangular titanium implants for SIJ fusion. Left: machined iFuse implant (commercially available since 2009). Right: 3D-printed implant (iFuse-3D, commercially available since early 2017). Bottom: X-ray image of implants after placement across the left SIJ. Abbreviation: SIJ, sacroiliac joint.
Figure 2
Figure 2
Cumulative probability of implant revision surgery after iFuse or iFuse-3D. Abbreviation: SIJF, sacroiliac joint fusion.
See this image and copyright information in PMC

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