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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.

17 linked reportsInjury 15Malfunction 2
11232019-01: 0 reports for this device; peer average 1.9/device2019-02: 0 reports for this device; peer average 1.96/device2019-03: 0 reports for this device; peer average 1.62/device2019-04: 0 reports for this device; peer average 1.9/device2019-05: 0 reports for this device; peer average 1.74/device2019-06: 0 reports for this device; peer average 2.03/device2019-07: 0 reports for this device; peer average 1.94/device2019-08: 0 reports for this device; peer average 2.11/device2019-09: 0 reports for this device; peer average 1.86/device2019-10: 0 reports for this device; peer average 2.21/device2019-11: 0 reports for this device; peer average 2.73/device2019-12: 0 reports for this device; peer average 2.22/device2020-01: 0 reports for this device; peer average 2.22/device2020-02: 0 reports for this device; peer average 2.55/device2020-03: 0 reports for this device; peer average 2.11/device2020-04: 0 reports for this device; peer average 2.02/device2020-05: 0 reports for this device; peer average 1.71/device2020-06: 0 reports for this device; peer average 1.96/device2020-07: 0 reports for this device; peer average 2.49/device2020-08: 0 reports for this device; peer average 2.54/device2020-09: 0 reports for this device; peer average 2.1/device2020-10: 0 reports for this device; peer average 2.65/device2020-11: 0 reports for this device; peer average 2.59/device2020-12: 0 reports for this device; peer average 2.69/device2021-01: 0 reports for this device; peer average 2.25/device2021-02: 0 reports for this device; peer average 2.24/device2021-03: 0 reports for this device; peer average 2.39/device2021-04: 0 reports for this device; peer average 2.21/device2021-05: 0 reports for this device; peer average 2.16/device2021-06: 0 reports for this device; peer average 2.05/device2021-07: 0 reports for this device; peer average 2.04/device2021-08: 0 reports for this device; peer average 1.75/device2021-09: 0 reports for this device; peer average 2.13/device2021-10: 0 reports for this device; peer average 1.81/device2021-11: 0 reports for this device; peer average 2.1/device2021-12: 0 reports for this device; peer average 2.16/device2022-01: 0 reports for this device; peer average 1.87/device2022-02: 0 reports for this device; peer average 2.2/device2022-03: 0 reports for this device; peer average 1.87/device2022-04: 0 reports for this device; peer average 1.93/device2022-05: 0 reports for this device; peer average 2.11/device2022-06: 0 reports for this device; peer average 1.87/device2022-07: 1 reports for this device; peer average 1.92/device2022-08: 0 reports for this device; peer average 1.94/device2022-09: 0 reports for this device; peer average 2.07/device2022-10: 0 reports for this device; peer average 2.04/device2022-11: 0 reports for this device; peer average 2.1/device2022-12: 0 reports for this device; peer average 1.77/device2023-01: 0 reports for this device; peer average 1.92/device2023-02: 0 reports for this device; peer average 2.05/device2023-03: 0 reports for this device; peer average 2.04/device2023-04: 1 reports for this device; peer average 2.1/device2023-05: 0 reports for this device; peer average 2.22/device2023-06: 1 reports for this device; peer average 2.1/device2023-07: 1 reports for this device; peer average 1.87/device2023-08: 0 reports for this device; peer average 1.59/device2023-09: 0 reports for this device; peer average 1.64/device2023-10: 0 reports for this device; peer average 1.53/device2023-11: 0 reports for this device; peer average 1.59/device2023-12: 0 reports for this device; peer average 1.59/device2024-01: 0 reports for this device; peer average 1.47/device2024-02: 1 reports for this device; peer average 1.63/device2024-03: 0 reports for this device; peer average 1.68/device2024-04: 0 reports for this device; peer average 1.56/device2024-05: 0 reports for this device; peer average 1.76/device2024-06: 1 reports for this device; peer average 1.84/device2024-07: 1 reports for this device; peer average 1.7/device2024-08: 0 reports for this device; peer average 2.16/device2024-09: 1 reports for this device; peer average 1.85/device2024-10: 0 reports for this device; peer average 1.85/device2024-11: 0 reports for this device; peer average 1.81/device2024-12: 0 reports for this device; peer average 1.92/device2025-01: 1 reports for this device; peer average 2.12/device2025-02: 1 reports for this device; peer average 1.71/device2025-03: 1 reports for this device; peer average 1.69/device2025-04: 0 reports for this device; peer average 1.56/device2025-05: 1 reports for this device; peer average 1.61/device2025-06: 0 reports for this device; peer average 1.68/device2025-07: 0 reports for this device; peer average 1.53/device2025-08: 2 reports for this device; peer average 1.56/device2025-09: 2 reports for this device; peer average 1.53/device2025-10: 0 reports for this device; peer average 1.38/device2025-11: 0 reports for this device; peer average 1.58/device2025-12: 1 reports for this device; peer average 1.57/device2026-01: 0 reports for this device; peer average 1.47/device2026-02: 0 reports for this device; peer average 1.46/device2026-03: 0 reports for this device; peer average 1.81/device2026-04: 0 reports for this device; peer average 1.62/device2026-05: 0 reports for this device; peer average 1.59/device2026-06: 0 reports for this device; peer average 1.57/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.9
2019-0201.96
2019-0301.62
2019-0401.9
2019-0501.74
2019-0602.03
2019-0701.94
2019-0802.11
2019-0901.86
2019-1002.21
2019-1102.73
2019-1202.22
2020-0102.22
2020-0202.55
2020-0302.11
2020-0402.02
2020-0501.71
2020-0601.96
2020-0702.49
2020-0802.54
2020-0902.1
2020-1002.65
2020-1102.59
2020-1202.69
2021-0102.25
2021-0202.24
2021-0302.39
2021-0402.21
2021-0502.16
2021-0602.05
2021-0702.04
2021-0801.75
2021-0902.13
2021-1001.81
2021-1102.1
2021-1202.16
2022-0101.87
2022-0202.2
2022-0301.87
2022-0401.93
2022-0502.11
2022-0601.87
2022-0711.92
2022-0801.94
2022-0902.07
2022-1002.04
2022-1102.1
2022-1201.77
2023-0101.92
2023-0202.05
2023-0302.04
2023-0412.1
2023-0502.22
2023-0612.1
2023-0711.87
2023-0801.59
2023-0901.64
2023-1001.53
2023-1101.59
2023-1201.59
2024-0101.47
2024-0211.63
2024-0301.68
2024-0401.56
2024-0501.76
2024-0611.84
2024-0711.7
2024-0802.16
2024-0911.85
2024-1001.85
2024-1101.81
2024-1201.92
2025-0112.12
2025-0211.71
2025-0311.69
2025-0401.56
2025-0511.61
2025-0601.68
2025-0701.53
2025-0821.56
2025-0921.53
2025-1001.38
2025-1101.58
2025-1211.57
2026-0101.47
2026-0201.46
2026-0301.81
2026-0401.62
2026-0501.59
2026-0601.57
This device (reports/month)Average device in JWH, MBH (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2025-12-030002249697-2025-01406InjuryAvailableexact di
2025-09-150002249697-2025-00981InjuryAvailableexact di
2025-09-040002249697-2025-00948MalfunctionAvailableexact di
2025-08-190002249697-2025-00890InjuryAvailableexact di
2025-08-190002249697-2025-00888InjuryAvailableexact di
2025-05-190002249697-2025-00521InjuryAvailableexact di
2025-03-270002249697-2025-00342InjuryAvailableexact di
2025-02-050002249697-2025-00141InjuryAvailableexact di
2025-01-060002249697-2025-00013InjuryAvailableexact di
2024-09-250002249697-2024-01321InjuryAvailableexact di
2024-07-090002249697-2024-00976InjuryAvailableexact di
2024-06-030002249697-2024-00832MalfunctionAvailableexact di
2024-02-060002249697-2024-00178InjuryAvailableexact di
2023-07-240002249697-2023-00823InjuryAvailableexact di
2023-06-220002249697-2023-00697InjuryAvailableexact di
Showing 1–15 of 17
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
    2023-12-01VAIVoluntary action indicatedHowmedica Osteonics Corp.1
    2021-06-22NAINo action indicatedHowmedica Osteonics Corp.0
    2015-03-09VAIVoluntary action indicatedHowmedica Osteonics Corp.3
    2013-04-16VAIVoluntary action indicatedHowmedica Osteonics Corp.3
    2010-01-15NAINo action indicatedHowmedica Osteonics Corp.0
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