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.

2 linked reportsInjury 2

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

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2019-05-22	3007700286-2019-00062	Injury	Available	exact di

Showing the most recent 1 of 2 linked reports.

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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