Skip to content
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 reportsInjury 49
13452019-01: 1 reports for this device; peer average 2.99/device2019-02: 5 reports for this device; peer average 2.56/device2019-03: 1 reports for this device; peer average 2.88/device2019-04: 0 reports for this device; peer average 2.72/device2019-05: 3 reports for this device; peer average 2.13/device2019-06: 2 reports for this device; peer average 1.85/device2019-07: 1 reports for this device; peer average 1.85/device2019-08: 2 reports for this device; peer average 2.16/device2019-09: 2 reports for this device; peer average 2.36/device2019-10: 2 reports for this device; peer average 2.57/device2019-11: 1 reports for this device; peer average 2.16/device2019-12: 0 reports for this device; peer average 2.45/device2020-01: 1 reports for this device; peer average 2.81/device2020-02: 0 reports for this device; peer average 2.54/device2020-03: 0 reports for this device; peer average 3.24/device2020-04: 1 reports for this device; peer average 2.27/device2020-05: 2 reports for this device; peer average 2.22/device2020-06: 2 reports for this device; peer average 2.06/device2020-07: 1 reports for this device; peer average 2.55/device2020-08: 1 reports for this device; peer average 2.03/device2020-09: 0 reports for this device; peer average 2.53/device2020-10: 4 reports for this device; peer average 2.53/device2020-11: 1 reports for this device; peer average 2.31/device2020-12: 0 reports for this device; peer average 2.32/device2021-01: 0 reports for this device; peer average 2.44/device2021-02: 2 reports for this device; peer average 2.05/device2021-03: 1 reports for this device; peer average 2.05/device2021-04: 0 reports for this device; peer average 2.07/device2021-05: 1 reports for this device; peer average 1.99/device2021-06: 0 reports for this device; peer average 2.49/device2021-07: 1 reports for this device; peer average 2.34/device2021-08: 0 reports for this device; peer average 2.29/device2021-09: 0 reports for this device; peer average 2.42/device2021-10: 0 reports for this device; peer average 2.21/device2021-11: 0 reports for this device; peer average 2.09/device2021-12: 0 reports for this device; peer average 2.32/device2022-01: 0 reports for this device; peer average 2.08/device2022-02: 0 reports for this device; peer average 2.12/device2022-03: 3 reports for this device; peer average 2.18/device2022-04: 0 reports for this device; peer average 2.17/device2022-05: 0 reports for this device; peer average 2.14/device2022-06: 0 reports for this device; peer average 2.24/device2022-07: 1 reports for this device; peer average 2.12/device2022-08: 0 reports for this device; peer average 2.22/device2022-09: 1 reports for this device; peer average 2.22/device2022-10: 0 reports for this device; peer average 2.18/device2022-11: 3 reports for this device; peer average 2.27/device2022-12: 0 reports for this device; peer average 2.18/device2023-01: 0 reports for this device; peer average 2.27/device2023-02: 1 reports for this device; peer average 2.16/device2023-03: 0 reports for this device; peer average 2.36/device2023-04: 0 reports for this device; peer average 2.31/device2023-05: 0 reports for this device; peer average 2.24/device2023-06: 0 reports for this device; peer average 2.34/device2023-07: 0 reports for this device; peer average 2.21/device2023-08: 0 reports for this device; peer average 2.06/device2023-09: 0 reports for this device; peer average 2.07/device2023-10: 0 reports for this device; peer average 1.72/device2023-11: 0 reports for this device; peer average 1.68/device2023-12: 0 reports for this device; peer average 1.77/device2024-01: 0 reports for this device; peer average 1.78/device2024-02: 0 reports for this device; peer average 2.1/device2024-03: 0 reports for this device; peer average 2.05/device2024-04: 0 reports for this device; peer average 1.84/device2024-05: 0 reports for this device; peer average 2.25/device2024-06: 0 reports for this device; peer average 2.03/device2024-07: 0 reports for this device; peer average 1.78/device2024-08: 0 reports for this device; peer average 2.01/device2024-09: 0 reports for this device; peer average 2.12/device2024-10: 0 reports for this device; peer average 1.84/device2024-11: 0 reports for this device; peer average 1.77/device2024-12: 0 reports for this device; peer average 1.61/device2025-01: 0 reports for this device; peer average 1.94/device2025-02: 0 reports for this device; peer average 1.56/device2025-03: 0 reports for this device; peer average 1.78/device2025-04: 0 reports for this device; peer average 1.83/device2025-05: 1 reports for this device; peer average 1.73/device2025-06: 0 reports for this device; peer average 1.85/device2025-07: 0 reports for this device; peer average 1.83/device2025-08: 0 reports for this device; peer average 1.73/device2025-09: 0 reports for this device; peer average 1.75/device2025-10: 0 reports for this device; peer average 1.73/device2025-11: 0 reports for this device; peer average 1.81/device2025-12: 0 reports for this device; peer average 1.9/device2026-01: 0 reports for this device; peer average 1.98/device2026-02: 1 reports for this device; peer average 1.68/device2026-03: 0 reports for this device; peer average 2.01/device2026-04: 0 reports for this device; peer average 1.89/device2026-05: 0 reports for this device; peer average 1.75/device2026-06: 0 reports for this device; peer average 1.79/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0112.99
2019-0252.56
2019-0312.88
2019-0402.72
2019-0532.13
2019-0621.85
2019-0711.85
2019-0822.16
2019-0922.36
2019-1022.57
2019-1112.16
2019-1202.45
2020-0112.81
2020-0202.54
2020-0303.24
2020-0412.27
2020-0522.22
2020-0622.06
2020-0712.55
2020-0812.03
2020-0902.53
2020-1042.53
2020-1112.31
2020-1202.32
2021-0102.44
2021-0222.05
2021-0312.05
2021-0402.07
2021-0511.99
2021-0602.49
2021-0712.34
2021-0802.29
2021-0902.42
2021-1002.21
2021-1102.09
2021-1202.32
2022-0102.08
2022-0202.12
2022-0332.18
2022-0402.17
2022-0502.14
2022-0602.24
2022-0712.12
2022-0802.22
2022-0912.22
2022-1002.18
2022-1132.27
2022-1202.18
2023-0102.27
2023-0212.16
2023-0302.36
2023-0402.31
2023-0502.24
2023-0602.34
2023-0702.21
2023-0802.06
2023-0902.07
2023-1001.72
2023-1101.68
2023-1201.77
2024-0101.78
2024-0202.1
2024-0302.05
2024-0401.84
2024-0502.25
2024-0602.03
2024-0701.78
2024-0802.01
2024-0902.12
2024-1001.84
2024-1101.77
2024-1201.61
2025-0101.94
2025-0201.56
2025-0301.78
2025-0401.83
2025-0511.73
2025-0601.85
2025-0701.83
2025-0801.73
2025-0901.75
2025-1001.73
2025-1101.81
2025-1201.9
2026-0101.98
2026-0211.68
2026-0302.01
2026-0401.89
2026-0501.75
2026-0601.79
This device (reports/month)Average device in JDI, LPH, LWJ, LZO, MEH (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
2026-02-090002249697-2026-00083InjuryAvailableexact di
2025-05-200002249697-2025-00526InjuryAvailableexact di
2023-02-150002249697-2023-00159InjuryAvailableexact di
2022-11-240002249697-2022-01727InjuryAvailableexact di
2022-11-180002249697-2022-01662InjuryAvailableexact di
2022-11-040002249697-2022-01583InjuryAvailableexact di
2022-09-120002249697-2022-01326InjuryAvailableexact di
2022-07-130002249697-2022-01004InjuryAvailableexact di
2022-03-230002249697-2022-00423InjuryAvailableexact di
2022-03-070002249697-2022-00334InjuryAvailableexact di
2022-03-010002249697-2022-00290InjuryAvailableexact di
2021-07-060002249697-2021-01139InjuryAvailableexact di
2021-05-060002249697-2021-00806InjuryAvailableexact di
2021-03-040002249697-2021-00376InjuryAvailableexact di
2021-02-260002249697-2021-00349InjuryAvailableexact di
Showing 115 of 49
Regulatory clearances

None linked.

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
Similar devices
Select up to two to place side-by-side with this device.