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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.

52 linked reportsInjury 52
2551761022019-01: 0 reports for this device; peer average 4.02/device2019-02: 0 reports for this device; peer average 5.49/device2019-03: 0 reports for this device; peer average 4.31/device2019-04: 0 reports for this device; peer average 4.35/device2019-05: 0 reports for this device; peer average 4.17/device2019-06: 0 reports for this device; peer average 7.53/device2019-07: 0 reports for this device; peer average 6.39/device2019-08: 0 reports for this device; peer average 5.67/device2019-09: 6 reports for this device; peer average 101.74/device2019-10: 0 reports for this device; peer average 19.81/device2019-11: 0 reports for this device; peer average 16.08/device2019-12: 1 reports for this device; peer average 30.69/device2020-01: 6 reports for this device; peer average 21.27/device2020-02: 0 reports for this device; peer average 20.62/device2020-03: 9 reports for this device; peer average 27.38/device2020-04: 0 reports for this device; peer average 11.97/device2020-05: 0 reports for this device; peer average 16.48/device2020-06: 0 reports for this device; peer average 19.79/device2020-07: 0 reports for this device; peer average 20.77/device2020-08: 0 reports for this device; peer average 21.31/device2020-09: 0 reports for this device; peer average 21.29/device2020-10: 2 reports for this device; peer average 24.87/device2020-11: 0 reports for this device; peer average 25.78/device2020-12: 3 reports for this device; peer average 23.76/device2021-01: 2 reports for this device; peer average 25.39/device2021-02: 0 reports for this device; peer average 23.01/device2021-03: 0 reports for this device; peer average 26.58/device2021-04: 0 reports for this device; peer average 27.25/device2021-05: 0 reports for this device; peer average 26.71/device2021-06: 6 reports for this device; peer average 25.72/device2021-07: 0 reports for this device; peer average 26.62/device2021-08: 2 reports for this device; peer average 25.87/device2021-09: 3 reports for this device; peer average 26.57/device2021-10: 1 reports for this device; peer average 13.4/device2021-11: 4 reports for this device; peer average 37.66/device2021-12: 0 reports for this device; peer average 40.89/device2022-01: 0 reports for this device; peer average 37.75/device2022-02: 0 reports for this device; peer average 34.42/device2022-03: 0 reports for this device; peer average 36.79/device2022-04: 0 reports for this device; peer average 35.22/device2022-05: 0 reports for this device; peer average 37.22/device2022-06: 0 reports for this device; peer average 36.79/device2022-07: 0 reports for this device; peer average 35.39/device2022-08: 2 reports for this device; peer average 37.6/device2022-09: 0 reports for this device; peer average 36.7/device2022-10: 0 reports for this device; peer average 42.21/device2022-11: 0 reports for this device; peer average 39.36/device2022-12: 0 reports for this device; peer average 41.85/device2023-01: 4 reports for this device; peer average 34.77/device2023-02: 0 reports for this device; peer average 35.66/device2023-03: 0 reports for this device; peer average 41.37/device2023-04: 0 reports for this device; peer average 38.17/device2023-05: 0 reports for this device; peer average 41.87/device2023-06: 0 reports for this device; peer average 45.96/device2023-07: 0 reports for this device; peer average 39.31/device2023-08: 0 reports for this device; peer average 33.01/device2023-09: 0 reports for this device; peer average 31.49/device2023-10: 0 reports for this device; peer average 33.43/device2023-11: 0 reports for this device; peer average 36.94/device2023-12: 0 reports for this device; peer average 34.53/device2024-01: 0 reports for this device; peer average 34.21/device2024-02: 0 reports for this device; peer average 34.57/device2024-03: 0 reports for this device; peer average 34.07/device2024-04: 0 reports for this device; peer average 37.37/device2024-05: 0 reports for this device; peer average 34.78/device2024-06: 0 reports for this device; peer average 33.12/device2024-07: 0 reports for this device; peer average 32.62/device2024-08: 0 reports for this device; peer average 31.39/device2024-09: 0 reports for this device; peer average 36.84/device2024-10: 0 reports for this device; peer average 36.67/device2024-11: 0 reports for this device; peer average 30.96/device2024-12: 0 reports for this device; peer average 26.15/device2025-01: 0 reports for this device; peer average 24.35/device2025-02: 0 reports for this device; peer average 23.19/device2025-03: 0 reports for this device; peer average 25.54/device2025-04: 0 reports for this device; peer average 14.63/device2025-05: 0 reports for this device; peer average 10.86/device2025-06: 0 reports for this device; peer average 51.12/device2025-07: 0 reports for this device; peer average 38.65/device2025-08: 0 reports for this device; peer average 31.25/device2025-09: 0 reports for this device; peer average 24.9/device2025-10: 0 reports for this device; peer average 23.31/device2025-11: 0 reports for this device; peer average 25.93/device2025-12: 0 reports for this device; peer average 29.86/device2026-01: 1 reports for this device; peer average 27.04/device2026-02: 0 reports for this device; peer average 27.07/device2026-03: 0 reports for this device; peer average 26.64/device2026-04: 0 reports for this device; peer average 25.99/device2026-05: 0 reports for this device; peer average 26.41/device2026-06: 0 reports for this device; peer average 27.45/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0104.02
2019-0205.49
2019-0304.31
2019-0404.35
2019-0504.17
2019-0607.53
2019-0706.39
2019-0805.67
2019-096101.74
2019-10019.81
2019-11016.08
2019-12130.69
2020-01621.27
2020-02020.62
2020-03927.38
2020-04011.97
2020-05016.48
2020-06019.79
2020-07020.77
2020-08021.31
2020-09021.29
2020-10224.87
2020-11025.78
2020-12323.76
2021-01225.39
2021-02023.01
2021-03026.58
2021-04027.25
2021-05026.71
2021-06625.72
2021-07026.62
2021-08225.87
2021-09326.57
2021-10113.4
2021-11437.66
2021-12040.89
2022-01037.75
2022-02034.42
2022-03036.79
2022-04035.22
2022-05037.22
2022-06036.79
2022-07035.39
2022-08237.6
2022-09036.7
2022-10042.21
2022-11039.36
2022-12041.85
2023-01434.77
2023-02035.66
2023-03041.37
2023-04038.17
2023-05041.87
2023-06045.96
2023-07039.31
2023-08033.01
2023-09031.49
2023-10033.43
2023-11036.94
2023-12034.53
2024-01034.21
2024-02034.57
2024-03034.07
2024-04037.37
2024-05034.78
2024-06033.12
2024-07032.62
2024-08031.39
2024-09036.84
2024-10036.67
2024-11030.96
2024-12026.15
2025-01024.35
2025-02023.19
2025-03025.54
2025-04014.63
2025-05010.86
2025-06051.12
2025-07038.65
2025-08031.25
2025-09024.9
2025-10023.31
2025-11025.93
2025-12029.86
2026-01127.04
2026-02027.07
2026-03026.64
2026-04025.99
2026-05026.41
2026-06027.45
This device (reports/month)Average device in DZE (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
2026-01-283001617766-2026-005437InjuryAvailableexact di
2023-01-263001617766-2023-00296InjuryAvailablecatalog number
2023-01-243001617766-2023-00224InjuryAvailablecatalog number
2022-08-163001617766-2022-04167InjuryAvailablecatalog number
2021-11-193001617766-2021-06819InjuryAvailablecatalog number
2021-11-033001617766-2021-06412InjuryAvailablecatalog number
2021-10-223001617766-2021-06195InjuryAvailableexact di
2021-09-033001617766-2021-05196InjuryAvailableexact di
2021-09-033001617766-2021-05195InjuryAvailablecatalog number
2021-08-183001617766-2021-04924InjuryAvailablecatalog number
2021-06-303001617766-2021-03839InjuryAvailablecatalog number
2021-06-303001617766-2021-03849InjuryAvailablecatalog number
2021-06-033001617766-2021-03277InjuryAvailablecatalog number
2021-01-203001617766-2021-00313InjuryAvailablecatalog number
2020-12-303001617766-2020-09231InjuryAvailableexact di

Showing the most recent 26 of 52 linked reports.

Showing 1–15 of 26
Regulatory clearances

    Predicate lineage

    K081396

    Cited as predicate by: K120530, K130572, K131097, K153509, K200265, K222211

    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
    2021-05-12VAIVoluntary action indicatedImplant Direct Sybron Manufacturing LLC1
    2019-12-02OAIOfficial action indicatedImplant Direct Sybron Manufacturing LLC5
    2015-04-21NAINo action indicatedImplant Direct Sybron Manufacturing LLC0
    2014-04-03NAINo action indicatedImplant Direct Sybron Manufacturing LLC0
    2012-02-10NAINo action indicatedImplant Direct Sybron Manufacturing LLC0
    2011-08-16NAINo action indicatedImplant Direct Sybron Manufacturing LLC0
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