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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.

34 linked reportsInjury 34
23562019-01: 0 reports for this device; peer average 1.33/device2019-02: 0 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 1/device2019-04: 0 reports for this device; peer average 1/device2019-05: 0 reports for this device; peer average 1/device2019-06: 0 reports for this device; peer average 1.25/device2019-08: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 1/device2019-11: 0 reports for this device; peer average 1.22/device2019-12: 0 reports for this device; peer average 1.4/device2020-01: 0 reports for this device; peer average 1.2/device2020-02: 0 reports for this device; peer average 2.5/device2020-04: 0 reports for this device; peer average 2.33/device2020-05: 0 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 1.9/device2020-07: 0 reports for this device; peer average 1/device2020-08: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 2/device2020-10: 0 reports for this device; peer average 1.67/device2020-11: 0 reports for this device; peer average 1.23/device2020-12: 0 reports for this device; peer average 1.5/device2021-01: 0 reports for this device; peer average 1.5/device2021-02: 0 reports for this device; peer average 1.17/device2021-03: 0 reports for this device; peer average 1.17/device2021-04: 0 reports for this device; peer average 1.14/device2021-05: 0 reports for this device; peer average 3/device2021-06: 0 reports for this device; peer average 1.7/device2021-07: 0 reports for this device; peer average 1.5/device2021-08: 0 reports for this device; peer average 1.67/device2021-09: 0 reports for this device; peer average 1.67/device2021-10: 0 reports for this device; peer average 1.75/device2021-11: 0 reports for this device; peer average 1.33/device2021-12: 0 reports for this device; peer average 2.25/device2022-01: 0 reports for this device; peer average 1.44/device2022-02: 0 reports for this device; peer average 1.44/device2022-03: 0 reports for this device; peer average 2.14/device2022-04: 0 reports for this device; peer average 1.78/device2022-05: 0 reports for this device; peer average 2.29/device2022-06: 0 reports for this device; peer average 1.5/device2022-07: 0 reports for this device; peer average 1.56/device2022-08: 3 reports for this device; peer average 2.08/device2022-09: 0 reports for this device; peer average 2.17/device2022-10: 0 reports for this device; peer average 2/device2022-11: 0 reports for this device; peer average 2.19/device2022-12: 0 reports for this device; peer average 2/device2023-01: 0 reports for this device; peer average 2.5/device2023-02: 0 reports for this device; peer average 1.4/device2023-03: 0 reports for this device; peer average 2.27/device2023-04: 0 reports for this device; peer average 1.43/device2023-05: 0 reports for this device; peer average 1.54/device2023-06: 0 reports for this device; peer average 1.67/device2023-07: 0 reports for this device; peer average 1.63/device2023-08: 0 reports for this device; peer average 1.36/device2023-09: 0 reports for this device; peer average 1.22/device2023-10: 0 reports for this device; peer average 1.64/device2023-11: 0 reports for this device; peer average 1.31/device2023-12: 0 reports for this device; peer average 1.13/device2024-01: 2 reports for this device; peer average 2.21/device2024-02: 0 reports for this device; peer average 1/device2024-03: 2 reports for this device; peer average 1.53/device2024-04: 0 reports for this device; peer average 1.41/device2024-05: 0 reports for this device; peer average 1.2/device2024-06: 6 reports for this device; peer average 2.33/device2024-07: 0 reports for this device; peer average 1.39/device2024-08: 4 reports for this device; peer average 2.05/device2024-09: 4 reports for this device; peer average 3.93/device2024-10: 2 reports for this device; peer average 1.61/device2024-11: 0 reports for this device; peer average 1.58/device2024-12: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 1.21/device2025-02: 0 reports for this device; peer average 1.22/device2025-03: 0 reports for this device; peer average 1.11/device2025-04: 1 reports for this device; peer average 1.29/device2025-05: 0 reports for this device; peer average 1/device2025-06: 0 reports for this device; peer average 1.15/device2025-07: 0 reports for this device; peer average 1.21/device2025-08: 0 reports for this device; peer average 1.33/device2025-09: 0 reports for this device; peer average 1.17/device2025-10: 4 reports for this device; peer average 2.03/device2025-11: 2 reports for this device; peer average 1.87/device2025-12: 0 reports for this device; peer average 1.67/device2026-01: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 1/device2026-03: 2 reports for this device; peer average 1.33/device2026-04: 2 reports for this device; peer average 1.55/device2026-05: 0 reports for this device; peer average 1.48/device2026-06: 0 reports for this device; peer average 1/device010203040506081011120102040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.33
2019-0201
2019-0301
2019-0401
2019-0501
2019-0601.25
2019-0801
2019-1001
2019-1101.22
2019-1201.4
2020-0101.2
2020-0202.5
2020-0402.33
2020-0501
2020-0601.9
2020-0701
2020-0801
2020-0902
2020-1001.67
2020-1101.23
2020-1201.5
2021-0101.5
2021-0201.17
2021-0301.17
2021-0401.14
2021-0503
2021-0601.7
2021-0701.5
2021-0801.67
2021-0901.67
2021-1001.75
2021-1101.33
2021-1202.25
2022-0101.44
2022-0201.44
2022-0302.14
2022-0401.78
2022-0502.29
2022-0601.5
2022-0701.56
2022-0832.08
2022-0902.17
2022-1002
2022-1102.19
2022-1202
2023-0102.5
2023-0201.4
2023-0302.27
2023-0401.43
2023-0501.54
2023-0601.67
2023-0701.63
2023-0801.36
2023-0901.22
2023-1001.64
2023-1101.31
2023-1201.13
2024-0122.21
2024-0201
2024-0321.53
2024-0401.41
2024-0501.2
2024-0662.33
2024-0701.39
2024-0842.05
2024-0943.93
2024-1021.61
2024-1101.58
2024-1201
2025-0101.21
2025-0201.22
2025-0301.11
2025-0411.29
2025-0501
2025-0601.15
2025-0701.21
2025-0801.33
2025-0901.17
2025-1042.03
2025-1121.87
2025-1201.67
2026-0101
2026-0201
2026-0321.33
2026-0421.55
2026-0501.48
2026-0601
This device (reports/month)Average device in JDB, JDC (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2026-04-230001649390-2026-00372InjuryAvailablecatalog number
2026-03-100001649390-2026-00270InjuryAvailablecatalog number
2025-11-260001649390-2025-00866InjuryAvailablecatalog number
2025-10-160001649390-2025-00723InjuryAvailablecatalog number
2025-10-100001649390-2025-00710InjuryAvailablecatalog number
2025-04-280001649390-2025-00284InjuryAvailablecatalog number
2024-10-160001649390-2024-00597InjuryAvailablecatalog number
2024-09-050001649390-2024-00449InjuryAvailablecatalog number
2024-09-040001649390-2024-00423InjuryAvailablecatalog number
2024-08-150001649390-2024-00376InjuryAvailablecatalog number
2024-08-150001649390-2024-00372InjuryAvailablecatalog number
2024-06-260001649390-2024-00285InjuryAvailablecatalog number
2024-06-120001649390-2024-00267InjuryAvailablecatalog number
2024-06-110001649390-2024-00259InjuryAvailablecatalog number
2024-03-010001649390-2024-00077InjuryAvailablecatalog number

Showing the most recent 17 of 34 linked reports.

Showing 1–15 of 17
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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