iFuse Implant System · recalls, adverse events, clearances

Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

37 linked reportsInjury 37

Monthly adverse-event reports for this device versus the product-code average.
Month	This device (reports)	Product-code average (reports per device)
2019-01	5	2.8
2019-02	0	2
2019-03	0	2.29
2019-04	1	2.13
2019-05	0	2.08
2019-06	0	2
2019-07	1	2.09
2019-08	1	2.5
2019-09	0	2
2019-10	2	2.43
2019-11	2	1.86
2019-12	2	1.83
2020-01	0	2.25
2020-02	0	3.14
2020-03	1	1.71
2020-04	0	1.33
2020-05	0	2.5
2020-06	2	2.14
2020-07	0	3
2020-08	3	2.2
2020-09	0	2.75
2020-10	2	2.5
2020-11	0	2.33
2020-12	1	2.22
2021-01	2	1.82
2021-02	0	2.4
2021-03	4	2.6
2021-04	0	1.92
2021-05	2	2.44
2021-06	2	1.8
2021-07	0	2
2021-08	0	3.75
2021-09	0	2
2021-10	0	1.56
2021-11	0	2.18
2021-12	2	2
2022-01	2	2
2022-02	0	3
2022-03	0	3
2022-04	0	2
2022-05	0	3
2022-07	0	1.75
2022-08	0	3
2022-12	0	3
2023-03	0	3
2023-04	0	2.67
2023-06	0	3
2023-07	0	2
2023-08	0	1
2024-02	0	1.5
2024-03	0	2
2024-04	0	2
2024-05	0	1.67
2024-08	0	1.86
2024-09	0	2
2024-10	0	2
2024-11	0	2
2024-12	0	2
2025-01	0	2.33
2025-02	0	4
2025-03	0	2
2025-05	0	2
2025-06	0	2
2025-07	0	1
2025-08	0	2
2025-09	0	1.67
2025-10	0	10
2025-11	0	2
2026-01	0	2
2026-02	0	1.5
2026-03	0	2
2026-04	0	2

This device (reports/month)Average device in OUR (reports/device/month)

Failure-mode summaryAI-generated

37 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2022-01-06	3007700286-2021-00144	Injury	Available	exact di
2021-12-22	3007700286-2021-00134	Injury	Available	exact di
2021-06-02	3007700286-2021-00059	Injury	Available	exact di
2021-05-19	3007700286-2021-00053	Injury	Available	exact di
2021-03-30	3007700286-2021-00024	Injury	Available	exact di
2021-03-01	3007700286-2021-00013	Injury	Available	exact di
2021-01-27	3007700286-2020-00135	Injury	Available	exact di
2020-12-10	3007700286-2020-00128	Injury	Available	exact di
2020-10-08	3007700286-2020-00087	Injury	Available	exact di
2020-08-18	3007700286-2020-00037	Injury	Available	exact di
2020-08-11	3007700286-2020-00065	Injury	Available	exact di
2020-06-02	3007700286-2020-00040	Injury	Available	exact di
2020-03-30	3007700286-2020-00034	Injury	Available	exact di
2019-12-12	3007700286-2019-00153	Injury	Available	exact di
2019-11-26	3007700286-2019-00142	Injury	Available	exact di

Showing the most recent 22 of 37 linked reports.

Showing 1–15 of 22

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2025-06-12	NAI	No action indicated	Si-Bone, Inc.	0
2025-06-12	NAI	No action indicated	Si-Bone, Inc.	0
2022-03-31	NAI	No action indicated	SI-BONE, Inc.	0
2022-03-31	NAI	No action indicated	SI-BONE, Inc.	0
2014-05-20	VAI	Voluntary action indicated	SI-BONE, Inc.	3
2014-05-20	VAI	Voluntary action indicated	SI-BONE, Inc.	3

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