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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
24572019-01: 0 reports for this device; peer average 1.57/device2019-02: 0 reports for this device; peer average 1.32/device2019-03: 0 reports for this device; peer average 1.78/device2019-04: 0 reports for this device; peer average 1.37/device2019-05: 0 reports for this device; peer average 1.56/device2019-06: 0 reports for this device; peer average 1.69/device2019-07: 0 reports for this device; peer average 1.57/device2019-08: 0 reports for this device; peer average 1.38/device2019-09: 0 reports for this device; peer average 1.62/device2019-10: 0 reports for this device; peer average 1.89/device2019-11: 0 reports for this device; peer average 1.5/device2019-12: 0 reports for this device; peer average 1.49/device2020-01: 0 reports for this device; peer average 1.67/device2020-02: 0 reports for this device; peer average 1.75/device2020-03: 0 reports for this device; peer average 1.51/device2020-04: 0 reports for this device; peer average 1.37/device2020-05: 0 reports for this device; peer average 1.49/device2020-06: 0 reports for this device; peer average 1.96/device2020-07: 0 reports for this device; peer average 2.29/device2020-08: 0 reports for this device; peer average 1.55/device2020-09: 0 reports for this device; peer average 2.48/device2020-10: 0 reports for this device; peer average 1.99/device2020-11: 0 reports for this device; peer average 2/device2020-12: 0 reports for this device; peer average 1.59/device2021-01: 0 reports for this device; peer average 1.64/device2021-02: 0 reports for this device; peer average 1.61/device2021-03: 0 reports for this device; peer average 1.9/device2021-04: 0 reports for this device; peer average 1.59/device2021-05: 0 reports for this device; peer average 1.79/device2021-06: 0 reports for this device; peer average 2.45/device2021-07: 0 reports for this device; peer average 1.75/device2021-08: 0 reports for this device; peer average 2.13/device2021-09: 0 reports for this device; peer average 1.67/device2021-10: 0 reports for this device; peer average 2.16/device2021-11: 0 reports for this device; peer average 1.83/device2021-12: 0 reports for this device; peer average 2.36/device2022-01: 0 reports for this device; peer average 2.72/device2022-02: 0 reports for this device; peer average 2.42/device2022-03: 0 reports for this device; peer average 1.77/device2022-04: 0 reports for this device; peer average 1.74/device2022-05: 0 reports for this device; peer average 2.18/device2022-06: 0 reports for this device; peer average 1.72/device2022-07: 0 reports for this device; peer average 1.95/device2022-08: 0 reports for this device; peer average 1.94/device2022-09: 0 reports for this device; peer average 1.95/device2022-10: 0 reports for this device; peer average 1.71/device2022-11: 0 reports for this device; peer average 1.85/device2022-12: 0 reports for this device; peer average 1.62/device2023-01: 0 reports for this device; peer average 2.25/device2023-02: 0 reports for this device; peer average 1.88/device2023-03: 0 reports for this device; peer average 1.92/device2023-04: 0 reports for this device; peer average 1.78/device2023-05: 0 reports for this device; peer average 1.73/device2023-06: 0 reports for this device; peer average 1.59/device2023-07: 0 reports for this device; peer average 2/device2023-08: 0 reports for this device; peer average 1.69/device2023-09: 0 reports for this device; peer average 1.85/device2023-10: 0 reports for this device; peer average 1.72/device2023-11: 0 reports for this device; peer average 7.17/device2023-12: 0 reports for this device; peer average 2.85/device2024-01: 0 reports for this device; peer average 1.86/device2024-02: 0 reports for this device; peer average 2.02/device2024-03: 0 reports for this device; peer average 1.88/device2024-04: 0 reports for this device; peer average 1.49/device2024-05: 0 reports for this device; peer average 1.83/device2024-06: 0 reports for this device; peer average 1.76/device2024-07: 0 reports for this device; peer average 1.88/device2024-08: 0 reports for this device; peer average 1.86/device2024-09: 2 reports for this device; peer average 1.82/device2024-10: 0 reports for this device; peer average 1.92/device2024-11: 0 reports for this device; peer average 1.69/device2024-12: 0 reports for this device; peer average 1.73/device2025-01: 0 reports for this device; peer average 1.71/device2025-02: 0 reports for this device; peer average 1.65/device2025-03: 0 reports for this device; peer average 1.97/device2025-04: 0 reports for this device; peer average 1.6/device2025-05: 0 reports for this device; peer average 1.84/device2025-06: 0 reports for this device; peer average 1.88/device2025-07: 0 reports for this device; peer average 1.83/device2025-08: 0 reports for this device; peer average 1.62/device2025-09: 0 reports for this device; peer average 1.65/device2025-10: 0 reports for this device; peer average 1.69/device2025-11: 0 reports for this device; peer average 1.8/device2025-12: 0 reports for this device; peer average 1.77/device2026-01: 0 reports for this device; peer average 1.71/device2026-02: 0 reports for this device; peer average 1.45/device2026-03: 0 reports for this device; peer average 2.42/device2026-04: 0 reports for this device; peer average 1.65/device2026-05: 0 reports for this device; peer average 1.59/device2026-06: 0 reports for this device; peer average 1.65/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.57
2019-0201.32
2019-0301.78
2019-0401.37
2019-0501.56
2019-0601.69
2019-0701.57
2019-0801.38
2019-0901.62
2019-1001.89
2019-1101.5
2019-1201.49
2020-0101.67
2020-0201.75
2020-0301.51
2020-0401.37
2020-0501.49
2020-0601.96
2020-0702.29
2020-0801.55
2020-0902.48
2020-1001.99
2020-1102
2020-1201.59
2021-0101.64
2021-0201.61
2021-0301.9
2021-0401.59
2021-0501.79
2021-0602.45
2021-0701.75
2021-0802.13
2021-0901.67
2021-1002.16
2021-1101.83
2021-1202.36
2022-0102.72
2022-0202.42
2022-0301.77
2022-0401.74
2022-0502.18
2022-0601.72
2022-0701.95
2022-0801.94
2022-0901.95
2022-1001.71
2022-1101.85
2022-1201.62
2023-0102.25
2023-0201.88
2023-0301.92
2023-0401.78
2023-0501.73
2023-0601.59
2023-0702
2023-0801.69
2023-0901.85
2023-1001.72
2023-1107.17
2023-1202.85
2024-0101.86
2024-0202.02
2024-0301.88
2024-0401.49
2024-0501.83
2024-0601.76
2024-0701.88
2024-0801.86
2024-0921.82
2024-1001.92
2024-1101.69
2024-1201.73
2025-0101.71
2025-0201.65
2025-0301.97
2025-0401.6
2025-0501.84
2025-0601.88
2025-0701.83
2025-0801.62
2025-0901.65
2025-1001.69
2025-1101.8
2025-1201.77
2026-0101.71
2026-0201.45
2026-0302.42
2026-0401.65
2026-0501.59
2026-0601.65
This device (reports/month)Average device in MAX, MQP, OVD (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
DateReport #TypeNarrativeLink basis
2024-09-182031966-2024-00240InjuryAvailableexact di

Showing the most recent 1 of 2 linked reports.

Regulatory clearances

    Predicate lineage

    K100043

    Cited as predicate by: K111166, K112561, K150135, K151214, K151665, K153782, K160051, K181386, K200953

    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
    DateTypeOutcomeFacilityCitations
    2024-05-06VAIVoluntary action indicatedNuVasive Specialized Orthopedics, Inc.12
    2024-01-18NAINo action indicatedNuvasive PR, Inc.0
    2019-12-09NAINo action indicatedNuvasive PR, Inc.0
    2019-07-29NAINo action indicatedNuVasive, Inc0
    2017-05-31NAINo action indicatedNuvasive PR, Inc.0
    2017-05-26VAIVoluntary action indicatedNuVasive Inc2
    2017-05-26VAIVoluntary action indicatedNuVasive Inc2
    2017-05-04VAIVoluntary action indicatedNuVasive, Inc3
    2016-10-26VAIVoluntary action indicatedNuvasive Inc2
    2014-11-19NAINo action indicatedNuVasive Inc0
    2014-11-19NAINo action indicatedNuVasive Inc0
    2014-08-27NAINo action indicatedNuvasive Inc4
    2014-04-01NAINo action indicatedNuvasive PR, Inc.0
    2014-02-20NAINo action indicatedNuVasive Specialized Orthopedics, Inc.0
    2014-02-05NAINo action indicatedNuVasive Inc0
    2014-02-05NAINo action indicatedNuVasive Inc0
    2013-03-12WLWarning LetterNuVasive Inc—
    2013-03-12WLWarning LetterNuVasive Inc—
    2012-11-02OAIOfficial action indicatedNuVasive Inc0
    2012-11-02OAIOfficial action indicatedNuVasive Inc0
    2012-02-10NAINo action indicatedNuVasive Inc0
    2012-02-10NAINo action indicatedNuVasive Inc0
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