Skip to content
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.

20 linked reportsInjury 14Malfunction 6
183654722019-01: 0 reports for this device; peer average 6.09/device2019-02: 0 reports for this device; peer average 5.59/device2019-03: 0 reports for this device; peer average 6.19/device2019-04: 0 reports for this device; peer average 7.81/device2019-05: 0 reports for this device; peer average 6.19/device2019-06: 0 reports for this device; peer average 4/device2019-07: 2 reports for this device; peer average 6.26/device2019-08: 0 reports for this device; peer average 7.14/device2019-09: 0 reports for this device; peer average 8.45/device2019-10: 0 reports for this device; peer average 6.87/device2019-11: 0 reports for this device; peer average 8.74/device2019-12: 0 reports for this device; peer average 7.84/device2020-01: 0 reports for this device; peer average 7.88/device2020-02: 0 reports for this device; peer average 5.09/device2020-03: 0 reports for this device; peer average 11.85/device2020-04: 0 reports for this device; peer average 10.61/device2020-05: 0 reports for this device; peer average 8.36/device2020-06: 0 reports for this device; peer average 6.16/device2020-07: 0 reports for this device; peer average 7.48/device2020-08: 0 reports for this device; peer average 8.52/device2020-09: 0 reports for this device; peer average 7.38/device2020-10: 3 reports for this device; peer average 10/device2020-11: 0 reports for this device; peer average 11.68/device2020-12: 0 reports for this device; peer average 11.65/device2021-01: 0 reports for this device; peer average 15.59/device2021-02: 0 reports for this device; peer average 13.16/device2021-03: 0 reports for this device; peer average 9.9/device2021-04: 0 reports for this device; peer average 11.75/device2021-05: 0 reports for this device; peer average 9.33/device2021-06: 0 reports for this device; peer average 7.84/device2021-07: 0 reports for this device; peer average 12.05/device2021-08: 0 reports for this device; peer average 9.17/device2021-09: 0 reports for this device; peer average 9.29/device2021-10: 0 reports for this device; peer average 11.68/device2021-11: 6 reports for this device; peer average 9.78/device2021-12: 0 reports for this device; peer average 10/device2022-01: 0 reports for this device; peer average 7.76/device2022-02: 0 reports for this device; peer average 11.54/device2022-03: 0 reports for this device; peer average 10.67/device2022-04: 0 reports for this device; peer average 6.19/device2022-05: 0 reports for this device; peer average 8.31/device2022-06: 0 reports for this device; peer average 7.57/device2022-07: 0 reports for this device; peer average 6.16/device2022-08: 0 reports for this device; peer average 8.39/device2022-09: 0 reports for this device; peer average 6.64/device2022-10: 3 reports for this device; peer average 8.06/device2022-11: 0 reports for this device; peer average 11.06/device2022-12: 0 reports for this device; peer average 8.96/device2023-01: 0 reports for this device; peer average 11.86/device2023-02: 0 reports for this device; peer average 12.58/device2023-03: 0 reports for this device; peer average 14.73/device2023-04: 0 reports for this device; peer average 14.78/device2023-05: 0 reports for this device; peer average 13.18/device2023-06: 0 reports for this device; peer average 16.77/device2023-07: 0 reports for this device; peer average 17.81/device2023-08: 0 reports for this device; peer average 20.46/device2023-09: 0 reports for this device; peer average 13.43/device2023-10: 0 reports for this device; peer average 16.51/device2023-11: 0 reports for this device; peer average 9.24/device2023-12: 2 reports for this device; peer average 15.57/device2024-01: 0 reports for this device; peer average 10.25/device2024-02: 0 reports for this device; peer average 16.66/device2024-03: 0 reports for this device; peer average 40.35/device2024-04: 0 reports for this device; peer average 61.7/device2024-05: 0 reports for this device; peer average 72.31/device2024-06: 0 reports for this device; peer average 69.97/device2024-07: 2 reports for this device; peer average 55.17/device2024-08: 0 reports for this device; peer average 32.98/device2024-09: 0 reports for this device; peer average 28.96/device2024-10: 0 reports for this device; peer average 17.14/device2024-11: 0 reports for this device; peer average 15.37/device2024-12: 0 reports for this device; peer average 10.96/device2025-01: 0 reports for this device; peer average 8.77/device2025-02: 0 reports for this device; peer average 7.59/device2025-03: 0 reports for this device; peer average 7.76/device2025-04: 0 reports for this device; peer average 10.04/device2025-05: 0 reports for this device; peer average 12.83/device2025-06: 0 reports for this device; peer average 13.22/device2025-07: 0 reports for this device; peer average 7.86/device2025-08: 2 reports for this device; peer average 7.7/device2025-09: 0 reports for this device; peer average 7/device2025-10: 0 reports for this device; peer average 7.05/device2025-11: 0 reports for this device; peer average 16.97/device2025-12: 0 reports for this device; peer average 8.75/device2026-01: 0 reports for this device; peer average 8.62/device2026-02: 0 reports for this device; peer average 18.97/device2026-03: 0 reports for this device; peer average 8.78/device2026-04: 0 reports for this device; peer average 11.63/device2026-05: 0 reports for this device; peer average 11.57/device2026-06: 0 reports for this device; peer average 14.08/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0106.09
2019-0205.59
2019-0306.19
2019-0407.81
2019-0506.19
2019-0604
2019-0726.26
2019-0807.14
2019-0908.45
2019-1006.87
2019-1108.74
2019-1207.84
2020-0107.88
2020-0205.09
2020-03011.85
2020-04010.61
2020-0508.36
2020-0606.16
2020-0707.48
2020-0808.52
2020-0907.38
2020-10310
2020-11011.68
2020-12011.65
2021-01015.59
2021-02013.16
2021-0309.9
2021-04011.75
2021-0509.33
2021-0607.84
2021-07012.05
2021-0809.17
2021-0909.29
2021-10011.68
2021-1169.78
2021-12010
2022-0107.76
2022-02011.54
2022-03010.67
2022-0406.19
2022-0508.31
2022-0607.57
2022-0706.16
2022-0808.39
2022-0906.64
2022-1038.06
2022-11011.06
2022-1208.96
2023-01011.86
2023-02012.58
2023-03014.73
2023-04014.78
2023-05013.18
2023-06016.77
2023-07017.81
2023-08020.46
2023-09013.43
2023-10016.51
2023-1109.24
2023-12215.57
2024-01010.25
2024-02016.66
2024-03040.35
2024-04061.7
2024-05072.31
2024-06069.97
2024-07255.17
2024-08032.98
2024-09028.96
2024-10017.14
2024-11015.37
2024-12010.96
2025-0108.77
2025-0207.59
2025-0307.76
2025-04010.04
2025-05012.83
2025-06013.22
2025-0707.86
2025-0827.7
2025-0907
2025-1007.05
2025-11016.97
2025-1208.75
2026-0108.62
2026-02018.97
2026-0308.78
2026-04011.63
2026-05011.57
2026-06014.08
This device (reports/month)Average device in GAT (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2025-08-221219602-2025-02071MalfunctionAvailablecatalog number
2024-07-031219602-2024-01430MalfunctionAvailablecatalog number
2023-12-141219602-2023-02444InjuryAvailablecatalog number
2022-10-311219602-2022-01639InjuryAvailablecatalog number
2021-11-301643264-2021-02442InjuryAvailableexact di
2021-11-301643264-2021-02444InjuryAvailableexact di
2021-11-301643264-2021-02443InjuryAvailableexact di
2020-10-061219602-2020-01527InjuryAvailablecatalog number
2019-07-151219602-2019-00812MalfunctionAvailablecatalog number

Showing the most recent 9 of 20 linked reports.

Regulatory clearances

    Predicate lineage

    K041216

    Cited as predicate by: K121861, K132357

    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
    2025-01-27NAINo action indicatedIntegrity Orthopaedics Inc0
    2023-05-03NAINo action indicatedCARTIHEAL, LTD0
    2021-12-09VAIVoluntary action indicatedSmith & Nephew, Inc.1
    2021-12-09VAIVoluntary action indicatedSmith & Nephew, Inc.1
    2021-10-26NAINo action indicatedSmith & Nephew Inc.0
    2021-10-26NAINo action indicatedSmith & Nephew Inc.0
    2020-02-06VAIVoluntary action indicatedBlue Belt Technologies, Inc6
    2019-10-25NAINo action indicatedTusker Medical, Inc.0
    2019-10-08VAIVoluntary action indicatedTusker Medical, Inc.3
    2018-03-30NAINo action indicatedAscension Orthopedics, Inc0
    2018-02-02NAINo action indicatedSmith & Nephew, Inc.0
    2018-02-02NAINo action indicatedSmith & Nephew, Inc.0
    2018-01-30NAINo action indicatedSmith & Nephew0
    2017-08-21NAINo action indicatedSmith & Nephew, Inc. Advanced Surgical Devices Division0
    2017-08-02VAIVoluntary action indicatedSmith & Nephew, Inc.3
    2017-08-02VAIVoluntary action indicatedSmith & Nephew, Inc.3
    2017-07-24NAINo action indicatedSmith & Nephew, Inc.0
    2017-07-24NAINo action indicatedSmith & Nephew, Inc.0
    2017-05-25NAINo action indicatedSmith & Nephew, Inc.0
    2017-05-25NAINo action indicatedSmith & Nephew, Inc.0
    2015-04-30WLWarning LetterSmith & Nephew Inc.—
    2015-04-30WLWarning LetterSmith & Nephew Inc.—
    2014-06-11WLWarning LetterSmith & Nephew, Inc.—
    2010-09-16WLWarning LetterAscension Orthopedics, Inc—
    Similar devices
    Select up to two to place side-by-side with this device.