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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.

37 linked reportsInjury 37
12332019-01: 0 reports for this device; peer average 2.01/device2019-02: 0 reports for this device; peer average 2.05/device2019-03: 0 reports for this device; peer average 1.66/device2019-04: 0 reports for this device; peer average 1.98/device2019-05: 3 reports for this device; peer average 1.81/device2019-06: 0 reports for this device; peer average 2.17/device2019-07: 0 reports for this device; peer average 2.01/device2019-08: 0 reports for this device; peer average 2.2/device2019-09: 0 reports for this device; peer average 1.96/device2019-10: 0 reports for this device; peer average 2.35/device2019-11: 0 reports for this device; peer average 2.93/device2019-12: 0 reports for this device; peer average 2.41/device2020-01: 3 reports for this device; peer average 2.33/device2020-02: 0 reports for this device; peer average 2.74/device2020-03: 3 reports for this device; peer average 2.3/device2020-04: 0 reports for this device; peer average 2.2/device2020-05: 0 reports for this device; peer average 1.81/device2020-06: 0 reports for this device; peer average 2.29/device2020-07: 0 reports for this device; peer average 2.85/device2020-08: 0 reports for this device; peer average 2.95/device2020-09: 0 reports for this device; peer average 2.45/device2020-10: 0 reports for this device; peer average 3.15/device2020-11: 0 reports for this device; peer average 3.18/device2020-12: 3 reports for this device; peer average 3.49/device2021-01: 0 reports for this device; peer average 2.8/device2021-02: 0 reports for this device; peer average 2.85/device2021-03: 0 reports for this device; peer average 2.61/device2021-04: 0 reports for this device; peer average 2.45/device2021-05: 0 reports for this device; peer average 2.8/device2021-06: 0 reports for this device; peer average 2.5/device2021-07: 0 reports for this device; peer average 2.5/device2021-08: 3 reports for this device; peer average 2.13/device2021-09: 0 reports for this device; peer average 2.74/device2021-10: 0 reports for this device; peer average 2.12/device2021-11: 0 reports for this device; peer average 2.53/device2021-12: 0 reports for this device; peer average 2.58/device2022-01: 0 reports for this device; peer average 2.24/device2022-02: 0 reports for this device; peer average 2.68/device2022-03: 0 reports for this device; peer average 2.4/device2022-04: 0 reports for this device; peer average 2.36/device2022-05: 3 reports for this device; peer average 2.87/device2022-06: 0 reports for this device; peer average 2.18/device2022-07: 0 reports for this device; peer average 2.33/device2022-08: 0 reports for this device; peer average 2.23/device2022-09: 0 reports for this device; peer average 2.36/device2022-10: 3 reports for this device; peer average 2.41/device2022-11: 0 reports for this device; peer average 2.37/device2022-12: 0 reports for this device; peer average 2.04/device2023-01: 0 reports for this device; peer average 2.21/device2023-02: 0 reports for this device; peer average 2.3/device2023-03: 0 reports for this device; peer average 2.26/device2023-04: 0 reports for this device; peer average 2.38/device2023-05: 0 reports for this device; peer average 2.46/device2023-06: 0 reports for this device; peer average 2.38/device2023-07: 0 reports for this device; peer average 2.03/device2023-08: 0 reports for this device; peer average 1.76/device2023-09: 0 reports for this device; peer average 1.77/device2023-10: 3 reports for this device; peer average 1.67/device2023-11: 3 reports for this device; peer average 1.79/device2023-12: 0 reports for this device; peer average 1.73/device2024-01: 0 reports for this device; peer average 1.67/device2024-02: 0 reports for this device; peer average 1.8/device2024-03: 0 reports for this device; peer average 1.84/device2024-04: 0 reports for this device; peer average 1.72/device2024-05: 0 reports for this device; peer average 1.91/device2024-06: 0 reports for this device; peer average 2.01/device2024-07: 3 reports for this device; peer average 1.91/device2024-08: 0 reports for this device; peer average 2.33/device2024-09: 0 reports for this device; peer average 2.03/device2024-10: 0 reports for this device; peer average 2.01/device2024-11: 0 reports for this device; peer average 2/device2024-12: 0 reports for this device; peer average 2.15/device2025-01: 0 reports for this device; peer average 2.32/device2025-02: 0 reports for this device; peer average 1.85/device2025-03: 0 reports for this device; peer average 1.88/device2025-04: 0 reports for this device; peer average 1.71/device2025-05: 0 reports for this device; peer average 1.74/device2025-06: 0 reports for this device; peer average 1.82/device2025-07: 0 reports for this device; peer average 1.68/device2025-08: 0 reports for this device; peer average 1.65/device2025-09: 0 reports for this device; peer average 1.71/device2025-10: 0 reports for this device; peer average 1.5/device2025-11: 3 reports for this device; peer average 1.73/device2025-12: 0 reports for this device; peer average 1.7/device2026-01: 0 reports for this device; peer average 1.56/device2026-02: 0 reports for this device; peer average 1.58/device2026-03: 2 reports for this device; peer average 2.03/device2026-04: 2 reports for this device; peer average 1.77/device2026-05: 0 reports for this device; peer average 1.77/device2026-06: 0 reports for this device; peer average 1.72/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.01
2019-0202.05
2019-0301.66
2019-0401.98
2019-0531.81
2019-0602.17
2019-0702.01
2019-0802.2
2019-0901.96
2019-1002.35
2019-1102.93
2019-1202.41
2020-0132.33
2020-0202.74
2020-0332.3
2020-0402.2
2020-0501.81
2020-0602.29
2020-0702.85
2020-0802.95
2020-0902.45
2020-1003.15
2020-1103.18
2020-1233.49
2021-0102.8
2021-0202.85
2021-0302.61
2021-0402.45
2021-0502.8
2021-0602.5
2021-0702.5
2021-0832.13
2021-0902.74
2021-1002.12
2021-1102.53
2021-1202.58
2022-0102.24
2022-0202.68
2022-0302.4
2022-0402.36
2022-0532.87
2022-0602.18
2022-0702.33
2022-0802.23
2022-0902.36
2022-1032.41
2022-1102.37
2022-1202.04
2023-0102.21
2023-0202.3
2023-0302.26
2023-0402.38
2023-0502.46
2023-0602.38
2023-0702.03
2023-0801.76
2023-0901.77
2023-1031.67
2023-1131.79
2023-1201.73
2024-0101.67
2024-0201.8
2024-0301.84
2024-0401.72
2024-0501.91
2024-0602.01
2024-0731.91
2024-0802.33
2024-0902.03
2024-1002.01
2024-1102
2024-1202.15
2025-0102.32
2025-0201.85
2025-0301.88
2025-0401.71
2025-0501.74
2025-0601.82
2025-0701.68
2025-0801.65
2025-0901.71
2025-1001.5
2025-1131.73
2025-1201.7
2026-0101.56
2026-0201.58
2026-0322.03
2026-0421.77
2026-0501.77
2026-0601.72
This device (reports/month)Average device in HRY, JWH (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2026-04-213010536692-2026-00169InjuryAvailablecatalog number
2026-03-193010536692-2026-00054InjuryAvailablecatalog number
2025-11-063010536692-2025-00359InjuryAvailablecatalog number
2024-07-183010536692-2024-00405InjuryAvailablecatalog number
2023-11-273010536692-2023-00215InjuryAvailablecatalog number
2023-10-253010536692-2023-00195InjuryAvailablecatalog number
2022-10-253010536692-2022-00375InjuryAvailablecatalog number
2022-05-113010536692-2022-00175InjuryAvailablecatalog number
2021-08-243010536692-2021-00448InjuryAvailablecatalog number
2020-12-023010536692-2020-00724InjuryAvailablecatalog number
2020-03-313010536692-2020-00302InjuryAvailablecatalog number
2020-01-103010536692-2020-00027InjuryAvailablecatalog number
2019-05-293010536692-2019-00774InjuryAvailablecatalog number

Showing the most recent 13 of 37 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2023-02-08NAINo action indicatedMicroPort Orthopedics Inc.0
2023-02-08NAINo action indicatedMicroPort Orthopedics Inc.0
2018-06-29VAIVoluntary action indicatedMicroPort Orthopedics Inc.2
2018-06-29VAIVoluntary action indicatedMicroPort Orthopedics Inc.2
2015-08-19VAIVoluntary action indicatedMicroPort Orthopedics Inc.5
2015-08-19VAIVoluntary action indicatedMicroPort Orthopedics Inc.5
2015-06-17WLWarning LetterMicroPort Orthopedics Inc.—
2015-06-17WLWarning LetterMicroPort Orthopedics Inc.—
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