Invictus · 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.

16 linked reportsMalfunction 16

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	2.5
2019-03	0	1.33
2019-04	0	2.5
2019-05	0	1.6
2019-06	0	2.25
2019-07	0	2.75
2019-08	0	2.33
2019-09	0	1.4
2019-10	0	2.5
2019-11	0	8
2019-12	0	2
2020-01	0	2
2020-02	0	2.44
2020-03	0	1
2020-04	0	1.33
2020-05	0	1.33
2020-06	0	1.33
2020-07	0	1.5
2020-08	0	2
2020-09	0	2.67
2020-10	0	2.33
2020-11	0	4
2020-12	0	2
2021-01	0	1.63
2021-02	0	2.67
2021-03	0	1
2021-04	0	2.5
2021-05	0	1.2
2021-06	0	1.33
2021-07	0	1.33
2021-08	0	2.25
2021-09	0	1
2021-10	0	1.67
2021-11	0	1.8
2021-12	0	1.33
2022-01	0	1.5
2022-02	0	4.5
2022-03	0	2.5
2022-04	0	1.5
2022-05	0	3.5
2022-06	0	1.2
2022-07	0	1.8
2022-08	0	2.5
2022-09	0	3
2022-10	0	2.83
2022-11	0	2.75
2022-12	0	2.5
2023-01	0	4
2023-02	0	2.67
2023-03	0	3
2023-04	0	2
2023-05	0	2
2023-06	0	1.5
2023-07	0	3.33
2023-08	0	2.33
2023-09	0	1.67
2023-10	0	1.6
2023-11	0	1.8
2023-12	0	1.5
2024-01	0	1.33
2024-02	0	1
2024-03	0	1.83
2024-04	0	1.5
2024-05	0	1
2024-06	0	1.86
2024-07	0	2
2024-08	0	1.5
2024-09	0	2.6
2024-10	4	2
2024-11	0	1.4
2024-12	0	1.8
2025-01	2	1.5
2025-02	0	1.25
2025-03	0	1
2025-04	0	1
2025-05	0	2
2025-06	2	1.89
2025-07	0	1.8
2025-08	0	2.67
2025-09	2	2.2
2025-10	0	1.4
2025-11	0	1.6
2025-12	0	4.6
2026-01	0	1.86
2026-02	0	2.36
2026-03	2	3
2026-04	0	2.6
2026-05	2	1.8
2026-06	2	1.5

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

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2026-06-29	2027467-2026-00129	Malfunction	Available	exact di
2026-05-11	2027467-2026-00088	Malfunction	Available	exact di
2026-03-19	2027467-2026-00044	Malfunction	Available	exact di
2025-09-11	2027467-2025-00214	Malfunction	Available	exact di
2025-06-09	2027467-2025-00123	Malfunction	Available	exact di
2025-01-10	2027467-2024-00176	Malfunction	Available	exact di
2024-10-14	2027467-2024-00121	Malfunction	Available	exact di
2024-10-14	2027467-2024-00123	Malfunction	Available	exact di

Showing the most recent 8 of 16 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2017-04-19	VAI	Voluntary action indicated	Alphatec Spine, Inc.	1
2016-03-16	VAI	Voluntary action indicated	Alphatec Spine, Inc.	1
2015-07-16	WL	Warning Letter	Alphatec Spine, Inc.	—
2015-03-13	OAI	Official action indicated	Alphatec Spine, Inc.	0
2013-06-14	NAI	No action indicated	Alphatec Spine, Inc.	0
2012-04-27	VAI	Voluntary action indicated	Alphatec Spine, Inc.	0
2011-01-11	WL	Warning Letter	Alphatec Spine, Inc.	—
2010-12-13	VAI	Voluntary action indicated	Alphatec Spine, Inc.	7
2010-06-21	WL	Warning Letter	Alphatec Spine, Inc.	—
2010-02-11	OAI	Official action indicated	Alphatec Spine, Inc.	11

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