Cohere · 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	1.52
2019-02	0	1.3
2019-03	0	1.7
2019-04	0	1.4
2019-05	0	1.56
2019-06	0	1.61
2019-07	0	1.6
2019-08	0	1.35
2019-09	0	1.66
2019-10	0	1.97
2019-11	0	1.55
2019-12	0	1.43
2020-01	0	1.69
2020-02	0	1.86
2020-03	0	1.5
2020-04	0	1.4
2020-05	0	1.59
2020-06	0	2.07
2020-07	0	2.23
2020-08	0	1.59
2020-09	0	2.78
2020-10	0	2.13
2020-11	0	2.37
2020-12	0	1.64
2021-01	0	1.81
2021-02	0	1.77
2021-03	0	1.95
2021-04	0	1.63
2021-05	0	2
2021-06	0	2.36
2021-07	0	1.83
2021-08	0	2.35
2021-09	0	1.72
2021-10	0	2.27
2021-11	0	1.91
2021-12	0	2.67
2022-01	0	3.2
2022-02	0	2.82
2022-03	0	1.8
2022-04	0	1.77
2022-05	0	2.28
2022-06	0	1.75
2022-07	0	2.18
2022-08	0	2.07
2022-09	0	1.89
2022-10	0	1.84
2022-11	0	1.87
2022-12	0	1.67
2023-01	0	2.25
2023-02	0	2
2023-03	0	1.73
2023-04	0	1.91
2023-05	0	1.91
2023-06	0	1.65
2023-07	0	2
2023-08	0	1.75
2023-09	0	1.91
2023-10	0	1.76
2023-11	0	8.27
2023-12	0	3.32
2024-01	0	1.94
2024-02	0	2.1
2024-03	0	1.85
2024-04	0	1.48
2024-05	0	1.93
2024-06	0	1.85
2024-07	0	1.98
2024-08	0	2.18
2024-09	0	1.88
2024-10	2	2.15
2024-11	0	1.74
2024-12	0	1.88
2025-01	0	1.82
2025-02	0	1.67
2025-03	0	1.67
2025-04	0	1.59
2025-05	0	1.64
2025-06	0	1.96
2025-07	0	1.95
2025-08	0	1.61
2025-09	0	1.73
2025-10	0	1.72
2025-11	0	1.91
2025-12	0	1.84
2026-01	0	1.79
2026-02	0	1.52
2026-03	0	2.66
2026-04	0	1.68
2026-05	0	1.57
2026-06	0	1.68

This device (reports/month)Average device in MAX, OVD, PHM (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
2024-10-29	2031966-2024-00284	Injury	Available	exact di

Showing the most recent 1 of 2 linked reports.

Regulatory clearances

Predicate lineage

K200953

Cited as predicate by: K203201, K203714, K250599

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2024-05-06	VAI	Voluntary action indicated	NuVasive Specialized Orthopedics, Inc.	12
2024-01-18	NAI	No action indicated	Nuvasive PR, Inc.	0
2019-12-09	NAI	No action indicated	Nuvasive PR, Inc.	0
2019-07-29	NAI	No action indicated	NuVasive, Inc	0
2017-05-31	NAI	No action indicated	Nuvasive PR, Inc.	0
2017-05-26	VAI	Voluntary action indicated	NuVasive Inc	2
2017-05-26	VAI	Voluntary action indicated	NuVasive Inc	2
2017-05-04	VAI	Voluntary action indicated	NuVasive, Inc	3
2016-10-26	VAI	Voluntary action indicated	Nuvasive Inc	2
2014-11-19	NAI	No action indicated	NuVasive Inc	0
2014-11-19	NAI	No action indicated	NuVasive Inc	0
2014-08-27	NAI	No action indicated	Nuvasive Inc	4
2014-04-01	NAI	No action indicated	Nuvasive PR, Inc.	0
2014-02-20	NAI	No action indicated	NuVasive Specialized Orthopedics, Inc.	0
2014-02-05	NAI	No action indicated	NuVasive Inc	0
2014-02-05	NAI	No action indicated	NuVasive Inc	0
2013-03-12	WL	Warning Letter	NuVasive Inc	—
2013-03-12	WL	Warning Letter	NuVasive Inc	—
2012-11-02	OAI	Official action indicated	NuVasive Inc	0
2012-11-02	OAI	Official action indicated	NuVasive Inc	0
2012-02-10	NAI	No action indicated	NuVasive Inc	0
2012-02-10	NAI	No action indicated	NuVasive Inc	0

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