MILLENNIUM · 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.

1 linked reportInjury 1

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	1.25
2019-02	0	1.33
2019-03	0	1.2
2019-04	0	1.2
2019-05	0	1.5
2019-06	0	2
2019-07	0	1
2019-08	0	1.14
2019-09	0	1
2019-10	0	3
2019-11	0	1.75
2019-12	0	1
2020-01	0	3.5
2020-02	0	1.25
2020-03	0	2.5
2020-04	0	1.43
2020-05	0	1
2020-06	0	2
2020-07	0	1
2020-08	0	1
2020-09	0	1
2020-10	0	1.5
2020-11	0	2.33
2020-12	0	2.33
2021-01	0	1.2
2021-02	0	2.5
2021-03	0	2.17
2021-04	0	2.75
2021-05	0	2
2021-06	0	1
2021-07	0	2.33
2021-08	0	2
2021-09	0	1.89
2021-10	0	2.5
2021-11	0	2.2
2021-12	0	1
2022-01	0	5
2022-02	0	1.67
2022-03	0	2.25
2022-04	0	1
2022-05	0	1
2022-06	0	2
2022-08	0	3
2022-09	0	1
2022-10	0	1
2022-11	0	2.75
2022-12	0	1.5
2023-01	0	1.67
2023-03	0	2.38
2023-04	0	2
2023-05	0	2
2023-06	0	1.5
2023-07	0	1
2023-08	0	1
2023-09	0	1.5
2023-10	0	1
2023-11	0	2.86
2023-12	0	1
2024-01	0	1.33
2024-02	0	1.5
2024-03	0	1.5
2024-04	0	2
2024-05	0	1
2024-06	0	1.45
2024-07	0	1.6
2024-08	0	1
2024-09	0	1.8
2024-10	0	1.71
2024-11	0	1.5
2024-12	0	1.63
2025-01	0	2.83
2025-02	0	2.33
2025-03	0	2.33
2025-04	0	2.2
2025-05	0	1.55
2025-06	0	2.29
2025-07	0	1.57
2025-08	0	1.33
2025-09	0	3.6
2025-10	1	1.71
2025-11	0	2.4
2025-12	0	2.6
2026-01	0	2.25
2026-02	0	1.45
2026-03	0	2.5
2026-04	0	1.67
2026-05	0	1.83
2026-06	0	2.71

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

Failure-mode summaryAI-generated

1 linked report narrative available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2025-10-15	3013111692-2025-29720	Injury	Available	exact di

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2023-12-05	VAI	Voluntary action indicated	Instrumed International Inc	5
2022-06-28	VAI	Voluntary action indicated	Avalign Integrated Medical Solutions, Inc.	3
2019-11-20	VAI	Voluntary action indicated	Instrumed International Inc	2
2018-10-25	NAI	No action indicated	Instrumed GmbH	0
2016-11-30	NAI	No action indicated	Instrumed International Inc	0
2015-09-22	NAI	No action indicated	Millennium Surgical Corp	0
2015-01-29	NAI	No action indicated	Instrumed GmbH	0
2014-03-28	WL	Warning Letter	Instrumed GmbH	—
2013-08-20	VAI	Voluntary action indicated	Instrumed International Inc	17
2013-08-01	OAI	Official action indicated	Instrumed GmbH	0
2013-04-24	VAI	Voluntary action indicated	Avalign Integrated Medical Solutions, Inc.	4
2011-02-28	NAI	No action indicated	Instrumed International Inc	0

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