Avalign · 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.

3 linked reportsMalfunction 3

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
2019-02	0	1
2019-03	0	1
2019-06	0	1
2019-07	0	1
2019-08	0	1
2019-10	0	1
2019-11	0	4
2019-12	0	1
2020-03	0	1
2020-06	0	1
2020-08	0	1
2020-10	0	1
2021-01	0	1
2021-04	0	1
2021-05	0	1.33
2021-06	0	1
2021-07	0	2.5
2021-10	0	1
2022-03	0	1
2022-04	0	1
2022-05	0	1
2022-06	0	1
2022-08	0	1
2022-09	0	1
2022-10	0	1
2022-11	0	1
2022-12	0	1
2023-01	0	2
2023-03	0	2.5
2023-04	0	1
2023-05	0	3.5
2023-06	0	3.5
2023-08	0	1
2023-09	0	2
2023-10	0	2
2023-11	0	3
2024-01	0	1
2024-02	0	1
2024-04	0	1
2024-05	0	1
2024-06	0	1
2024-07	1	1
2024-11	0	1
2024-12	0	1
2025-02	0	1
2025-04	0	1.5
2025-05	0	2
2025-06	0	2
2025-07	2	2
2025-08	0	1.67
2025-09	0	2
2025-12	0	1
2026-02	0	1.33
2026-03	0	1.33
2026-05	0	1
2026-06	0	1.5

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

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2025-07-25	1421101-2025-00001	Malfunction	Available	exact di
2024-07-30	1421101-2024-00004	Malfunction	Available	model number

Showing the most recent 2 of 3 linked reports.

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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