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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.

125 linked reportsInjury 120Malfunction 5
358102019-01: 0 reports for this device; peer average 1.82/device2019-02: 0 reports for this device; peer average 1.85/device2019-03: 0 reports for this device; peer average 1.75/device2019-04: 0 reports for this device; peer average 1.88/device2019-05: 0 reports for this device; peer average 2.1/device2019-06: 0 reports for this device; peer average 1.88/device2019-07: 0 reports for this device; peer average 1.68/device2019-08: 0 reports for this device; peer average 2.18/device2019-09: 0 reports for this device; peer average 1.67/device2019-10: 0 reports for this device; peer average 1.88/device2019-11: 0 reports for this device; peer average 1.72/device2019-12: 0 reports for this device; peer average 1.77/device2020-01: 0 reports for this device; peer average 1.96/device2020-02: 0 reports for this device; peer average 2.08/device2020-03: 0 reports for this device; peer average 2.19/device2020-04: 0 reports for this device; peer average 1.8/device2020-05: 0 reports for this device; peer average 1.66/device2020-06: 1 reports for this device; peer average 1.95/device2020-07: 0 reports for this device; peer average 2.24/device2020-08: 1 reports for this device; peer average 1.76/device2020-09: 0 reports for this device; peer average 1.96/device2020-10: 0 reports for this device; peer average 2.2/device2020-11: 0 reports for this device; peer average 1.9/device2020-12: 0 reports for this device; peer average 1.87/device2021-01: 0 reports for this device; peer average 2.2/device2021-02: 0 reports for this device; peer average 1.99/device2021-03: 0 reports for this device; peer average 2.15/device2021-04: 1 reports for this device; peer average 2.02/device2021-05: 0 reports for this device; peer average 2.02/device2021-06: 0 reports for this device; peer average 1.91/device2021-07: 0 reports for this device; peer average 2.06/device2021-08: 1 reports for this device; peer average 2.19/device2021-09: 0 reports for this device; peer average 1.97/device2021-10: 0 reports for this device; peer average 2.18/device2021-11: 0 reports for this device; peer average 2.13/device2021-12: 0 reports for this device; peer average 2.6/device2022-01: 0 reports for this device; peer average 2.65/device2022-02: 0 reports for this device; peer average 2.35/device2022-03: 0 reports for this device; peer average 2.51/device2022-04: 0 reports for this device; peer average 2.48/device2022-05: 0 reports for this device; peer average 2.13/device2022-06: 0 reports for this device; peer average 2.24/device2022-07: 0 reports for this device; peer average 2.2/device2022-08: 0 reports for this device; peer average 2.27/device2022-09: 0 reports for this device; peer average 2.04/device2022-10: 0 reports for this device; peer average 2.12/device2022-11: 0 reports for this device; peer average 2.16/device2022-12: 0 reports for this device; peer average 2.1/device2023-01: 5 reports for this device; peer average 1.85/device2023-02: 0 reports for this device; peer average 2.06/device2023-03: 0 reports for this device; peer average 2.05/device2023-04: 0 reports for this device; peer average 2.22/device2023-05: 5 reports for this device; peer average 2.12/device2023-06: 3 reports for this device; peer average 2.32/device2023-07: 3 reports for this device; peer average 2.11/device2023-08: 0 reports for this device; peer average 1.76/device2023-09: 3 reports for this device; peer average 1.59/device2023-10: 0 reports for this device; peer average 1.64/device2023-11: 3 reports for this device; peer average 1.69/device2023-12: 0 reports for this device; peer average 1.46/device2024-01: 0 reports for this device; peer average 1.9/device2024-02: 2 reports for this device; peer average 1.89/device2024-03: 2 reports for this device; peer average 1.73/device2024-04: 2 reports for this device; peer average 1.87/device2024-05: 0 reports for this device; peer average 1.72/device2024-06: 1 reports for this device; peer average 1.89/device2024-07: 2 reports for this device; peer average 1.63/device2024-08: 2 reports for this device; peer average 1.73/device2024-09: 8 reports for this device; peer average 1.74/device2024-10: 2 reports for this device; peer average 1.73/device2024-11: 0 reports for this device; peer average 1.64/device2024-12: 0 reports for this device; peer average 1.67/device2025-01: 1 reports for this device; peer average 1.74/device2025-02: 6 reports for this device; peer average 1.65/device2025-03: 2 reports for this device; peer average 1.94/device2025-04: 6 reports for this device; peer average 1.73/device2025-05: 6 reports for this device; peer average 1.83/device2025-06: 4 reports for this device; peer average 1.96/device2025-07: 4 reports for this device; peer average 1.8/device2025-08: 2 reports for this device; peer average 1.61/device2025-09: 2 reports for this device; peer average 1.52/device2025-10: 4 reports for this device; peer average 1.69/device2025-11: 2 reports for this device; peer average 1.74/device2025-12: 9 reports for this device; peer average 2.19/device2026-01: 10 reports for this device; peer average 1.93/device2026-02: 10 reports for this device; peer average 1.85/device2026-03: 2 reports for this device; peer average 1.8/device2026-04: 1 reports for this device; peer average 1.74/device2026-05: 5 reports for this device; peer average 1.8/device2026-06: 2 reports for this device; peer average 1.8/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.82
2019-0201.85
2019-0301.75
2019-0401.88
2019-0502.1
2019-0601.88
2019-0701.68
2019-0802.18
2019-0901.67
2019-1001.88
2019-1101.72
2019-1201.77
2020-0101.96
2020-0202.08
2020-0302.19
2020-0401.8
2020-0501.66
2020-0611.95
2020-0702.24
2020-0811.76
2020-0901.96
2020-1002.2
2020-1101.9
2020-1201.87
2021-0102.2
2021-0201.99
2021-0302.15
2021-0412.02
2021-0502.02
2021-0601.91
2021-0702.06
2021-0812.19
2021-0901.97
2021-1002.18
2021-1102.13
2021-1202.6
2022-0102.65
2022-0202.35
2022-0302.51
2022-0402.48
2022-0502.13
2022-0602.24
2022-0702.2
2022-0802.27
2022-0902.04
2022-1002.12
2022-1102.16
2022-1202.1
2023-0151.85
2023-0202.06
2023-0302.05
2023-0402.22
2023-0552.12
2023-0632.32
2023-0732.11
2023-0801.76
2023-0931.59
2023-1001.64
2023-1131.69
2023-1201.46
2024-0101.9
2024-0221.89
2024-0321.73
2024-0421.87
2024-0501.72
2024-0611.89
2024-0721.63
2024-0821.73
2024-0981.74
2024-1021.73
2024-1101.64
2024-1201.67
2025-0111.74
2025-0261.65
2025-0321.94
2025-0461.73
2025-0561.83
2025-0641.96
2025-0741.8
2025-0821.61
2025-0921.52
2025-1041.69
2025-1121.74
2025-1292.19
2026-01101.93
2026-02101.85
2026-0321.8
2026-0411.74
2026-0551.8
2026-0621.8
This device (reports/month)Average device in KWS, PHX (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
2026-06-230001649390-2026-00614InjuryAvailablecatalog number
2026-05-290001649390-2026-00516InjuryAvailablecatalog number
2026-05-190001649390-2026-00449InjuryAvailableexact di
2026-05-150001649390-2026-00438InjuryAvailablecatalog number
2026-04-020001649390-2026-00325InjuryAvailableexact di
2026-03-030001649390-2026-00216InjuryAvailablecatalog number
2026-02-240001649390-2026-00188InjuryAvailablecatalog number
2026-02-190001649390-2026-00171InjuryAvailablecatalog number
2026-02-160001649390-2026-00151InjuryAvailablecatalog number
2026-02-130001649390-2026-00130InjuryAvailablecatalog number
2026-02-020001649390-2026-00092InjuryAvailablecatalog number
2026-01-260001649390-2026-00051InjuryAvailablecatalog number
2026-01-140001649390-2026-00040InjuryAvailablecatalog number
2026-01-130001649390-2026-00034InjuryAvailablecatalog number
2026-01-050001649390-2026-00001InjuryAvailablecatalog number

Showing the most recent 68 of 125 linked reports.

Showing 1–15 of 68
Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2015-07-15NAINo action indicatedTornier, Inc0
2015-01-22NAINo action indicatedTornier Inc.0
2014-03-26NAINo action indicatedTornier, Inc0
2013-01-31VAIVoluntary action indicatedTornier, Inc4
2011-11-03NAINo action indicatedTornier, Inc0
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