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

Daniel Cher,1 Kendrick Wroe,2 W Carlton Reckling,3 Scott Yerby4 1Clinical Affairs, SI-BONE, Inc., Santa Clara, CA, USA; 2Quality Assurance, SI-BONE, Inc., Santa Clara, CA, USA; 3Medical Affairs, SI-BONE, Inc., Santa Clara, CA, USA; 4Research and Development, SI-BONE, Inc., Santa Clara, CA, USA Backg...

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Autores principales:	Cher D, Wroe K, Reckling WC, Yerby S
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2018
Materias:	complaint analysis postmarket surveillance spine surgery sacroiliac joint fusion 3D-printed devices Medical technology R855-855.5
Acceso en línea:	https://doaj.org/article/128664ce29964857b3a121cf186cad34
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spelling	oai:doaj.org-article:128664ce29964857b3a121cf186cad342021-12-02T02:01:33ZPostmarket surveillance of 3D-printed implants for sacroiliac joint fusion1179-1470https://doaj.org/article/128664ce29964857b3a121cf186cad342018-09-01T00:00:00Zhttps://www.dovepress.com/postmarket-surveillance-of-3d-printed-implants-for-sacroiliac-joint-fu-peer-reviewed-article-MDERhttps://doaj.org/toc/1179-1470Daniel Cher,1 Kendrick Wroe,2 W Carlton Reckling,3 Scott Yerby4 1Clinical Affairs, SI-BONE, Inc., Santa Clara, CA, USA; 2Quality Assurance, SI-BONE, Inc., Santa Clara, CA, USA; 3Medical Affairs, SI-BONE, Inc., Santa Clara, CA, USA; 4Research and Development, SI-BONE, Inc., Santa Clara, CA, USA 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 fusionCher DWroe KReckling WCYerby SDove Medical Pressarticlecomplaint analysispostmarket surveillancespine surgerysacroiliac joint fusion3D-printed devicesMedical technologyR855-855.5ENMedical Devices: Evidence and Research, Vol Volume 11, Pp 337-343 (2018)
institution	DOAJ
collection	DOAJ
language	EN
topic	complaint analysis postmarket surveillance spine surgery sacroiliac joint fusion 3D-printed devices Medical technology R855-855.5
spellingShingle	complaint analysis postmarket surveillance spine surgery sacroiliac joint fusion 3D-printed devices Medical technology R855-855.5 Cher D Wroe K Reckling WC Yerby S Postmarket surveillance of 3D-printed implants for sacroiliac joint fusion
description	Daniel Cher,1 Kendrick Wroe,2 W Carlton Reckling,3 Scott Yerby4 1Clinical Affairs, SI-BONE, Inc., Santa Clara, CA, USA; 2Quality Assurance, SI-BONE, Inc., Santa Clara, CA, USA; 3Medical Affairs, SI-BONE, Inc., Santa Clara, CA, USA; 4Research and Development, SI-BONE, Inc., Santa Clara, CA, USA 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
format	article
author	Cher D Wroe K Reckling WC Yerby S
author_facet	Cher D Wroe K Reckling WC Yerby S
author_sort	Cher D
title	Postmarket surveillance of 3D-printed implants for sacroiliac joint fusion
title_short	Postmarket surveillance of 3D-printed implants for sacroiliac joint fusion
title_full	Postmarket surveillance of 3D-printed implants for sacroiliac joint fusion
title_fullStr	Postmarket surveillance of 3D-printed implants for sacroiliac joint fusion
title_full_unstemmed	Postmarket surveillance of 3D-printed implants for sacroiliac joint fusion
title_sort	postmarket surveillance of 3d-printed implants for sacroiliac joint fusion
publisher	Dove Medical Press
publishDate	2018
url	https://doaj.org/article/128664ce29964857b3a121cf186cad34
work_keys_str_mv	AT cherd postmarketsurveillanceof3dprintedimplantsforsacroiliacjointfusion AT wroek postmarketsurveillanceof3dprintedimplantsforsacroiliacjointfusion AT recklingwc postmarketsurveillanceof3dprintedimplantsforsacroiliacjointfusion AT yerbys postmarketsurveillanceof3dprintedimplantsforsacroiliacjointfusion
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Postmarket surveillance of 3D-printed implants for sacroiliac joint fusion

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