CoRoent · 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.

6 linked reportsMalfunction 4Injury 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
2019-02	0	1
2019-03	0	1.5
2019-04	0	1.5
2019-05	0	1.55
2019-06	0	1.2
2019-07	0	1.79
2019-08	0	4.29
2019-09	0	1.57
2019-10	0	2.93
2019-11	0	1.25
2019-12	0	1.33
2020-01	0	5.78
2020-02	0	1.5
2020-03	0	1.38
2020-04	0	1.36
2020-05	0	1.46
2020-06	0	1
2020-07	0	1.75
2020-08	0	1.31
2020-09	0	2
2020-10	0	1.6
2020-11	0	1.2
2020-12	2	1.71
2021-01	0	1.25
2021-02	0	2.83
2021-03	0	1.6
2021-04	0	1
2021-05	0	3.33
2021-06	0	3.6
2021-07	0	1.17
2021-08	0	1.4
2021-09	0	1.78
2021-10	0	1
2021-11	0	1
2021-12	0	1.58
2022-01	0	1.22
2022-02	0	1.44
2022-03	0	1.44
2022-04	0	1.08
2022-05	0	1.65
2022-06	0	1.64
2022-07	0	1.21
2022-08	0	1.27
2022-09	0	2.07
2022-10	0	1.3
2022-11	0	1.56
2022-12	0	1.71
2023-01	0	3
2023-02	0	1.82
2023-03	0	2.37
2023-04	0	1.44
2023-05	2	1.4
2023-06	0	1.29
2023-07	0	1.25
2023-08	0	3.35
2023-09	0	1
2023-10	0	1.78
2023-11	0	1
2023-12	0	1.4
2024-01	0	1.88
2024-02	2	1.5
2024-03	0	1.75
2024-04	0	1.6
2024-05	0	1.69
2024-06	0	2.75
2024-07	0	1.33
2024-08	0	1.64
2024-09	0	1.6
2024-10	0	1.38
2024-11	0	1.38
2024-12	0	1.55
2025-01	0	1.47
2025-02	0	1.93
2025-03	0	1.95
2025-04	0	1.81
2025-05	0	1.46
2025-06	0	2
2025-07	0	2.21
2025-08	0	1.55
2025-09	0	1.57
2025-10	0	1.53
2025-11	0	2
2025-12	0	1.55
2026-01	0	1.53
2026-02	0	1.53
2026-03	0	1.59
2026-04	0	1.3
2026-05	0	2.67
2026-06	0	2.81

This device (reports/month)Average device in ODP, OVE (reports/device/month)

Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports

Date	Report #	Type	Narrative	Link basis
2024-02-08	2031966-2024-00046	Malfunction	Available	exact di
2023-05-16	2031966-2021-00003	Injury	Available	exact di
2020-12-23	2031966-2020-00219	Malfunction	Available	exact di

Showing the most recent 3 of 6 linked reports.

Regulatory clearances

Predicate lineage

K102547

Cited as predicate by: K131880, K142299, K151198, K153250, K161442

K142299

Cited as predicate by: K161442, K192582

K161442

Cited as predicate by: K173115, K173722

K170961

Cited as predicate by: K181621, K231735

K192582

Cited as predicate by: K212612, K212904, K213359, K222973, K231735

K231735

Cited as predicate by: K240830, K241375, K253876

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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