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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.

49 linked reportsMalfunction 41Injury 8
358102019-01: 0 reports for this device; peer average 1.54/device2019-02: 0 reports for this device; peer average 1.22/device2019-03: 1 reports for this device; peer average 1.69/device2019-04: 0 reports for this device; peer average 1.46/device2019-05: 1 reports for this device; peer average 1.6/device2019-06: 2 reports for this device; peer average 1.57/device2019-07: 5 reports for this device; peer average 1.65/device2019-08: 1 reports for this device; peer average 1.36/device2019-09: 2 reports for this device; peer average 1.32/device2019-10: 1 reports for this device; peer average 1.83/device2019-11: 1 reports for this device; peer average 1.58/device2019-12: 1 reports for this device; peer average 1.36/device2020-01: 0 reports for this device; peer average 1.67/device2020-02: 0 reports for this device; peer average 1.73/device2020-03: 0 reports for this device; peer average 1.45/device2020-04: 0 reports for this device; peer average 1.43/device2020-05: 2 reports for this device; peer average 1.64/device2020-06: 2 reports for this device; peer average 1.84/device2020-07: 1 reports for this device; peer average 1.85/device2020-08: 2 reports for this device; peer average 1.63/device2020-09: 2 reports for this device; peer average 2.52/device2020-10: 1 reports for this device; peer average 2.05/device2020-11: 1 reports for this device; peer average 2.1/device2020-12: 3 reports for this device; peer average 1.76/device2021-01: 1 reports for this device; peer average 1.7/device2021-02: 0 reports for this device; peer average 1.72/device2021-03: 1 reports for this device; peer average 2/device2021-04: 1 reports for this device; peer average 1.55/device2021-05: 0 reports for this device; peer average 1.6/device2021-06: 3 reports for this device; peer average 2.23/device2021-07: 0 reports for this device; peer average 1.73/device2021-08: 1 reports for this device; peer average 2.21/device2021-09: 1 reports for this device; peer average 1.72/device2021-10: 0 reports for this device; peer average 2.11/device2021-11: 0 reports for this device; peer average 1.84/device2021-12: 0 reports for this device; peer average 2.54/device2022-01: 0 reports for this device; peer average 3.14/device2022-02: 0 reports for this device; peer average 2.62/device2022-03: 1 reports for this device; peer average 1.78/device2022-04: 0 reports for this device; peer average 1.76/device2022-05: 0 reports for this device; peer average 2.13/device2022-06: 0 reports for this device; peer average 1.79/device2022-07: 0 reports for this device; peer average 2.21/device2022-08: 0 reports for this device; peer average 1.86/device2022-09: 0 reports for this device; peer average 1.78/device2022-10: 0 reports for this device; peer average 1.87/device2022-11: 0 reports for this device; peer average 1.93/device2022-12: 0 reports for this device; peer average 1.7/device2023-01: 9 reports for this device; peer average 2.44/device2023-02: 0 reports for this device; peer average 2.05/device2023-03: 0 reports for this device; peer average 1.71/device2023-04: 0 reports for this device; peer average 1.81/device2023-05: 0 reports for this device; peer average 2.04/device2023-06: 0 reports for this device; peer average 1.75/device2023-07: 0 reports for this device; peer average 2.04/device2023-08: 0 reports for this device; peer average 1.73/device2023-09: 1 reports for this device; peer average 1.97/device2023-10: 0 reports for this device; peer average 1.85/device2023-11: 0 reports for this device; peer average 10.03/device2023-12: 1 reports for this device; peer average 3.95/device2024-01: 0 reports for this device; peer average 1.86/device2024-02: 0 reports for this device; peer average 2.13/device2024-03: 0 reports for this device; peer average 1.9/device2024-04: 0 reports for this device; peer average 1.36/device2024-05: 0 reports for this device; peer average 1.58/device2024-06: 0 reports for this device; peer average 1.79/device2024-07: 0 reports for this device; peer average 1.93/device2024-08: 0 reports for this device; peer average 2.27/device2024-09: 0 reports for this device; peer average 1.9/device2024-10: 0 reports for this device; peer average 2.13/device2024-11: 0 reports for this device; peer average 1.74/device2024-12: 0 reports for this device; peer average 1.69/device2025-01: 0 reports for this device; peer average 1.85/device2025-02: 0 reports for this device; peer average 1.66/device2025-03: 0 reports for this device; peer average 1.66/device2025-04: 0 reports for this device; peer average 1.6/device2025-05: 0 reports for this device; peer average 1.65/device2025-06: 0 reports for this device; peer average 2.02/device2025-07: 0 reports for this device; peer average 1.81/device2025-08: 0 reports for this device; peer average 1.61/device2025-09: 0 reports for this device; peer average 1.59/device2025-10: 0 reports for this device; peer average 1.71/device2025-11: 0 reports for this device; peer average 2.03/device2025-12: 0 reports for this device; peer average 1.85/device2026-01: 0 reports for this device; peer average 1.94/device2026-02: 0 reports for this device; peer average 1.53/device2026-03: 0 reports for this device; peer average 2.76/device2026-04: 0 reports for this device; peer average 1.57/device2026-05: 0 reports for this device; peer average 1.58/device2026-06: 0 reports for this device; peer average 1.6/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.54
2019-0201.22
2019-0311.69
2019-0401.46
2019-0511.6
2019-0621.57
2019-0751.65
2019-0811.36
2019-0921.32
2019-1011.83
2019-1111.58
2019-1211.36
2020-0101.67
2020-0201.73
2020-0301.45
2020-0401.43
2020-0521.64
2020-0621.84
2020-0711.85
2020-0821.63
2020-0922.52
2020-1012.05
2020-1112.1
2020-1231.76
2021-0111.7
2021-0201.72
2021-0312
2021-0411.55
2021-0501.6
2021-0632.23
2021-0701.73
2021-0812.21
2021-0911.72
2021-1002.11
2021-1101.84
2021-1202.54
2022-0103.14
2022-0202.62
2022-0311.78
2022-0401.76
2022-0502.13
2022-0601.79
2022-0702.21
2022-0801.86
2022-0901.78
2022-1001.87
2022-1101.93
2022-1201.7
2023-0192.44
2023-0202.05
2023-0301.71
2023-0401.81
2023-0502.04
2023-0601.75
2023-0702.04
2023-0801.73
2023-0911.97
2023-1001.85
2023-11010.03
2023-1213.95
2024-0101.86
2024-0202.13
2024-0301.9
2024-0401.36
2024-0501.58
2024-0601.79
2024-0701.93
2024-0802.27
2024-0901.9
2024-1002.13
2024-1101.74
2024-1201.69
2025-0101.85
2025-0201.66
2025-0301.66
2025-0401.6
2025-0501.65
2025-0602.02
2025-0701.81
2025-0801.61
2025-0901.59
2025-1001.71
2025-1102.03
2025-1201.85
2026-0101.94
2026-0201.53
2026-0302.76
2026-0401.57
2026-0501.58
2026-0601.6
This device (reports/month)Average device in MAX (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
2023-12-298030965-2023-16258MalfunctionAvailableexact di
2023-09-278030965-2023-12207MalfunctionAvailableexact di
2023-01-268030965-2023-00967MalfunctionAvailableexact di
2023-01-238030965-2023-00759MalfunctionAvailableexact di
2023-01-128030965-2023-00464MalfunctionAvailableexact di
2023-01-128030965-2023-00467MalfunctionAvailableexact di
2023-01-128030965-2023-00466MalfunctionAvailableexact di
2022-03-178030965-2022-01699MalfunctionAvailableexact di
2021-09-218030965-2021-07917MalfunctionAvailableexact di
2021-08-048030965-2021-06413MalfunctionAvailableexact di
2021-06-218030965-2021-05118MalfunctionAvailableexact di
2021-06-108030965-2021-04772MalfunctionAvailableexact di
2021-06-108030965-2021-04770MalfunctionAvailableexact di
2021-04-298030965-2021-03445MalfunctionAvailableexact di
2021-03-038030965-2021-01557InjuryAvailableexact di

Showing the most recent 45 of 49 linked reports.

Showing 1–15 of 45
Regulatory clearances

    Predicate lineage

    K151276

    Cited as predicate by: K162358, K181231, K203714

    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
    2017-08-08NAINo action indicatedSynthes GmbH0
    2017-01-18NAINo action indicatedSynthes (USA), LLC0
    2015-05-08VAIVoluntary action indicatedSynthes (USA), LLC2
    2013-11-13VAIVoluntary action indicatedSynthes, Inc.1
    2013-05-16NAINo action indicatedSynthes, Inc.0
    2012-10-19VAIVoluntary action indicatedSynthes, Inc.1
    2012-02-16WLWarning LetterSynthes, Inc.—
    2012-02-01NAINo action indicatedSynthes (USA), LLC0
    2011-09-15OAIOfficial action indicatedSynthes, Inc.10
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