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.

39 linked reportsInjury 39

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

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2022-07-08	3007700286-2022-00004	Injury	Available	exact di
2021-11-23	3007700286-2021-00119	Injury	Available	exact di
2021-07-26	3007700286-2021-00076	Injury	Available	exact di
2021-06-08	3007700286-2021-00060	Injury	Available	exact di
2021-05-11	3007700286-2021-00041	Injury	Available	exact di
2021-05-03	3007700286-2021-00037	Injury	Available	exact di
2021-04-20	3007700286-2021-00032	Injury	Available	exact di
2021-01-28	3007700286-2021-00001	Injury	Available	model number
2020-12-01	3007700286-2020-00118	Injury	Available	exact di
2020-11-20	3007700286-2020-00113	Injury	Available	exact di
2020-11-17	3007700286-2020-00111	Injury	Available	exact di
2020-10-23	3007700286-2020-00097	Injury	Available	exact di
2020-10-15	3007700286-2020-00094	Injury	Available	exact di
2020-08-18	3007700286-2020-00068	Injury	Available	exact di
2020-06-16	3007700286-2020-00049	Injury	Available	exact di

Showing the most recent 23 of 39 linked reports.

Showing 1–15 of 23

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

Similar devices