VADER Pedicle System, Screw, Carbon/PEEK, Polyax., Fen., Ø 6.5 x 50 mm · 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	2.15
2019-02	0	2.1
2019-03	0	1.9
2019-04	0	2.06
2019-05	0	2.2
2019-06	0	2.5
2019-07	0	1.67
2019-08	0	2.94
2019-09	0	1.75
2019-10	0	1.92
2019-11	0	2.37
2019-12	0	1.59
2020-01	0	2.33
2020-02	0	2.21
2020-03	0	2.37
2020-04	0	1.58
2020-05	0	2.62
2020-06	0	1.69
2020-07	0	2.04
2020-08	0	2.06
2020-09	0	2.49
2020-10	0	2.71
2020-11	0	2.35
2020-12	0	1.9
2021-01	0	2.39
2021-02	0	1.89
2021-03	0	2.56
2021-04	0	2.4
2021-05	0	2
2021-06	0	2.31
2021-07	0	2.26
2021-08	0	2.01
2021-09	0	1.95
2021-10	0	2.5
2021-11	0	2.28
2021-12	0	2.49
2022-01	0	2.14
2022-02	0	2.1
2022-03	0	1.87
2022-04	0	2.04
2022-05	0	1.88
2022-06	0	2.04
2022-07	0	4.8
2022-08	0	1.77
2022-09	0	2.62
2022-10	0	1.6
2022-11	0	1.8
2022-12	0	2.25
2023-01	0	1.94
2023-02	0	1.83
2023-03	0	1.61
2023-04	0	1.86
2023-05	0	1.53
2023-06	0	1.74
2023-07	0	2.12
2023-08	0	2.24
2023-09	0	2.56
2023-10	0	2.69
2023-11	0	2.45
2023-12	0	1.74
2024-01	0	2.44
2024-02	0	2.21
2024-03	0	3.55
2024-04	0	1.69
2024-05	0	3.63
2024-06	0	3.02
2024-07	0	1.94
2024-08	0	1.99
2024-09	0	3.57
2024-10	0	2.25
2024-11	0	2.16
2024-12	0	2.1
2025-01	0	2.32
2025-02	0	2.66
2025-03	0	2.36
2025-04	0	2.39
2025-05	0	2.62
2025-06	0	2.24
2025-07	0	1.9
2025-08	0	2.02
2025-09	0	1.81
2025-10	0	1.79
2025-11	0	2.02
2025-12	0	2.66
2026-01	0	2.25
2026-02	0	2.38
2026-03	0	2.28
2026-04	0	1.91
2026-05	0	2.31
2026-06	2	3.81

This device (reports/month)Average device in NKB, PML (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
2026-06-02	3006493760-2026-00005	Injury	Available	exact di

Showing the most recent 1 of 2 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record

None in the loaded window.

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