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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.

2,248 linked reportsMalfunction 2,223Injury 25
183553702019-01: 30 reports for this device; peer average 12.92/device2019-02: 17 reports for this device; peer average 14.35/device2019-03: 29 reports for this device; peer average 14.05/device2019-04: 45 reports for this device; peer average 18.63/device2019-05: 53 reports for this device; peer average 19.54/device2019-06: 57 reports for this device; peer average 20.19/device2019-07: 22 reports for this device; peer average 13.37/device2019-08: 18 reports for this device; peer average 11.15/device2019-09: 24 reports for this device; peer average 11.95/device2019-10: 27 reports for this device; peer average 9.58/device2019-11: 33 reports for this device; peer average 11.88/device2019-12: 22 reports for this device; peer average 14.46/device2020-01: 21 reports for this device; peer average 11.27/device2020-02: 26 reports for this device; peer average 12.22/device2020-03: 27 reports for this device; peer average 12.88/device2020-04: 10 reports for this device; peer average 10.44/device2020-05: 10 reports for this device; peer average 15.5/device2020-06: 18 reports for this device; peer average 12.21/device2020-07: 20 reports for this device; peer average 14.34/device2020-08: 27 reports for this device; peer average 12.98/device2020-09: 23 reports for this device; peer average 12.31/device2020-10: 28 reports for this device; peer average 12.61/device2020-11: 30 reports for this device; peer average 14.12/device2020-12: 15 reports for this device; peer average 12.64/device2021-01: 27 reports for this device; peer average 11.89/device2021-02: 14 reports for this device; peer average 14.14/device2021-03: 28 reports for this device; peer average 13.25/device2021-04: 27 reports for this device; peer average 13.21/device2021-05: 29 reports for this device; peer average 14.8/device2021-06: 35 reports for this device; peer average 18.26/device2021-07: 25 reports for this device; peer average 13.79/device2021-08: 17 reports for this device; peer average 17.29/device2021-09: 24 reports for this device; peer average 24.68/device2021-10: 20 reports for this device; peer average 14.32/device2021-11: 28 reports for this device; peer average 16.72/device2021-12: 14 reports for this device; peer average 12.67/device2022-01: 14 reports for this device; peer average 10.59/device2022-02: 12 reports for this device; peer average 13.53/device2022-03: 24 reports for this device; peer average 15.09/device2022-04: 16 reports for this device; peer average 12.75/device2022-05: 15 reports for this device; peer average 16.55/device2022-06: 19 reports for this device; peer average 15.68/device2022-07: 25 reports for this device; peer average 12.74/device2022-08: 23 reports for this device; peer average 13.73/device2022-09: 20 reports for this device; peer average 15.67/device2022-10: 27 reports for this device; peer average 18.18/device2022-11: 17 reports for this device; peer average 16.94/device2022-12: 18 reports for this device; peer average 16.56/device2023-01: 22 reports for this device; peer average 14/device2023-02: 24 reports for this device; peer average 12.62/device2023-03: 21 reports for this device; peer average 16.68/device2023-04: 23 reports for this device; peer average 14.38/device2023-05: 24 reports for this device; peer average 16.67/device2023-06: 24 reports for this device; peer average 24.22/device2023-07: 33 reports for this device; peer average 25.39/device2023-08: 28 reports for this device; peer average 21.23/device2023-09: 26 reports for this device; peer average 17.03/device2023-10: 27 reports for this device; peer average 17.29/device2023-11: 25 reports for this device; peer average 18.43/device2023-12: 32 reports for this device; peer average 20.54/device2024-01: 22 reports for this device; peer average 25.65/device2024-02: 23 reports for this device; peer average 20.49/device2024-03: 23 reports for this device; peer average 21.69/device2024-04: 18 reports for this device; peer average 22.32/device2024-05: 25 reports for this device; peer average 18.44/device2024-06: 31 reports for this device; peer average 19.81/device2024-07: 29 reports for this device; peer average 23.6/device2024-08: 58 reports for this device; peer average 29.73/device2024-09: 46 reports for this device; peer average 22.75/device2024-10: 57 reports for this device; peer average 27.4/device2024-11: 26 reports for this device; peer average 14.37/device2024-12: 31 reports for this device; peer average 16.74/device2025-01: 30 reports for this device; peer average 16.27/device2025-02: 70 reports for this device; peer average 21.38/device2025-03: 37 reports for this device; peer average 25.24/device2025-04: 21 reports for this device; peer average 23.34/device2025-05: 23 reports for this device; peer average 20.44/device2025-06: 46 reports for this device; peer average 33.41/device2025-07: 25 reports for this device; peer average 20.35/device2025-08: 12 reports for this device; peer average 17.63/device2025-09: 13 reports for this device; peer average 19.99/device2025-10: 18 reports for this device; peer average 18.6/device2025-11: 11 reports for this device; peer average 16.83/device2025-12: 15 reports for this device; peer average 15.93/device2026-01: 17 reports for this device; peer average 17/device2026-02: 20 reports for this device; peer average 14.12/device2026-03: 20 reports for this device; peer average 15.06/device2026-04: 8 reports for this device; peer average 11.52/device2026-05: 8 reports for this device; peer average 11.51/device2026-06: 6 reports for this device; peer average 8.95/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-013012.92
2019-021714.35
2019-032914.05
2019-044518.63
2019-055319.54
2019-065720.19
2019-072213.37
2019-081811.15
2019-092411.95
2019-10279.58
2019-113311.88
2019-122214.46
2020-012111.27
2020-022612.22
2020-032712.88
2020-041010.44
2020-051015.5
2020-061812.21
2020-072014.34
2020-082712.98
2020-092312.31
2020-102812.61
2020-113014.12
2020-121512.64
2021-012711.89
2021-021414.14
2021-032813.25
2021-042713.21
2021-052914.8
2021-063518.26
2021-072513.79
2021-081717.29
2021-092424.68
2021-102014.32
2021-112816.72
2021-121412.67
2022-011410.59
2022-021213.53
2022-032415.09
2022-041612.75
2022-051516.55
2022-061915.68
2022-072512.74
2022-082313.73
2022-092015.67
2022-102718.18
2022-111716.94
2022-121816.56
2023-012214
2023-022412.62
2023-032116.68
2023-042314.38
2023-052416.67
2023-062424.22
2023-073325.39
2023-082821.23
2023-092617.03
2023-102717.29
2023-112518.43
2023-123220.54
2024-012225.65
2024-022320.49
2024-032321.69
2024-041822.32
2024-052518.44
2024-063119.81
2024-072923.6
2024-085829.73
2024-094622.75
2024-105727.4
2024-112614.37
2024-123116.74
2025-013016.27
2025-027021.38
2025-033725.24
2025-042123.34
2025-052320.44
2025-064633.41
2025-072520.35
2025-081217.63
2025-091319.99
2025-101818.6
2025-111116.83
2025-121515.93
2026-011717
2026-022014.12
2026-032015.06
2026-04811.52
2026-05811.51
2026-0668.95
This device (reports/month)Average device in HAW (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2026-06-301723170-2026-00940Malfunction—model number
2026-06-301723170-2026-00941Malfunction—model number
2026-06-291723170-2026-00934Malfunction—model number
2026-06-251723170-2026-00925Malfunction—model number
2026-06-221723170-2026-00909Malfunction—model number
2026-06-171723170-2026-00895MalfunctionAvailablemodel number
2026-05-261723170-2026-00798MalfunctionAvailablemodel number
2026-05-261723170-2026-00796MalfunctionAvailablemodel number
2026-05-181723170-2026-00762MalfunctionAvailablemodel number
2026-05-181723170-2026-00765MalfunctionAvailablemodel number
2026-05-131723170-2026-00737MalfunctionAvailablemodel number
2026-05-111723170-2026-00729MalfunctionAvailablemodel number
2026-05-111723170-2026-00727MalfunctionAvailablemodel number
2026-05-051723170-2026-00698MalfunctionAvailablemodel number
2026-04-271723170-2026-00660MalfunctionAvailablemodel number

Showing the most recent 200 of 2,248 linked reports.

Showing 1–15 of 200
Regulatory clearances

    Predicate lineage

    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
    2024-02-09VAIVoluntary action indicatedMedtronic Navigation, Inc.3
    2021-06-29VAIVoluntary action indicatedMedtronic Navigation, Inc.3
    2019-09-30VAIVoluntary action indicatedMedtronic Navigation, Inc.1
    2016-08-18VAIVoluntary action indicatedMedtronic Navigation, Inc.0
    2014-12-15NAINo action indicatedMedtronic Navigation, Inc.0
    2014-02-19VAIVoluntary action indicatedMedtronic Navigation, Inc.5
    2012-09-06NAINo action indicatedMedtronic Navigation, Inc.0
    2012-05-01NAINo action indicatedMedtronic Navigation, Inc.0
    2011-03-24VAIVoluntary action indicatedMedtronic Navigation, Inc.1
    2010-05-07WLWarning LetterMedtronic Navigation, Inc.—
    2010-02-04OAIOfficial action indicatedMedtronic Navigation, Inc.9
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