VERTEX® Reconstruction System · 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	2.13
2019-02	0	1.87
2019-03	2	1.91
2019-04	0	1.98
2019-05	0	2.19
2019-06	0	2.19
2019-07	0	1.63
2019-08	0	2.5
2019-09	0	1.79
2019-10	0	1.85
2019-11	0	2.12
2019-12	0	1.54
2020-01	0	2.35
2020-02	0	2.32
2020-03	0	2.33
2020-04	0	1.45
2020-05	0	2.16
2020-06	0	1.93
2020-07	0	1.72
2020-08	0	1.83
2020-09	0	2.09
2020-10	0	2.38
2020-11	0	2.23
2020-12	0	2.07
2021-01	0	2.1
2021-02	0	1.83
2021-03	0	2.2
2021-04	0	2.05
2021-05	0	1.96
2021-06	0	1.88
2021-07	0	6.91
2021-08	0	1.89
2021-09	0	1.69
2021-10	0	2.28
2021-11	0	1.97
2021-12	0	1.97
2022-01	0	2.05
2022-02	0	1.91
2022-03	0	1.68
2022-04	0	1.78
2022-05	0	1.68
2022-06	0	1.95
2022-07	0	3.29
2022-08	0	1.88
2022-09	0	2.72
2022-10	0	1.43
2022-11	0	1.57
2022-12	0	1.94
2023-01	0	1.61
2023-02	0	1.78
2023-03	0	1.77
2023-04	0	2
2023-05	0	1.57
2023-06	0	1.64
2023-07	0	1.73
2023-08	0	1.34
2023-09	0	2.57
2023-10	0	2.44
2023-11	0	2.19
2023-12	0	1.63
2024-01	0	2.39
2024-02	0	2.14
2024-03	0	3.63
2024-04	0	1.73
2024-05	0	3.39
2024-06	0	2.23
2024-07	0	1.78
2024-08	0	1.79
2024-09	0	2.58
2024-10	0	2.27
2024-11	0	1.88
2024-12	0	1.76
2025-01	0	2.31
2025-02	0	2.45
2025-03	0	2.18
2025-04	0	2.25
2025-05	0	2.5
2025-06	0	2.29
2025-07	0	1.72
2025-08	0	1.96
2025-09	0	1.88
2025-10	0	1.93
2025-11	0	1.97
2025-12	0	2.27
2026-01	0	2.39
2026-02	0	2.4
2026-03	0	2.34
2026-04	0	1.83
2026-05	0	2.19
2026-06	0	4.25

This device (reports/month)Average device in KWP (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
2019-03-29	1030489-2019-00340	Injury	Available	exact di
2019-03-29	1030489-2019-00339	Injury	Available	exact di

Regulatory clearances

Predicate lineage

K090714

Cited as predicate by: K121191, K121877, K123656, K163375, K181350, K223764

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
2026-02-06	NAI	No action indicated	Medtronic Sofamor Danek USA Inc	0
2017-10-26	NAI	No action indicated	Medtronic Sofamor Danek USA, Inc	0
2015-11-03	VAI	Voluntary action indicated	Medtronic Sofamor Danek USA Inc	0
2015-10-23	VAI	Voluntary action indicated	Medtronic Sofamor Danek USA Inc	1
2014-03-11	VAI	Voluntary action indicated	Medtronic Sofamor Danek USA Inc	0
2013-07-15	NAI	No action indicated	Medtronic Sofamor Danek USA, Inc	0
2013-07-15	NAI	No action indicated	Medtronic Sofamor Danek USA Inc	0
2012-06-06	VAI	Voluntary action indicated	Medtronic Sofamor Danek USA Inc	0
2011-02-23	NAI	No action indicated	Medtronic Sofamor Danek Usa Inc	0
2010-08-06	VAI	Voluntary action indicated	Medtronic Sofamor Danek USA Inc	0
2010-03-04	VAI	Voluntary action indicated	Medtronic Sofamor Danek USA Inc	0
2010-02-25	NAI	No action indicated	Medtronic Sofamor Danek USA Inc	0

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