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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.

102 linked reportsInjury 99Malfunction 3
24682019-01: 0 reports for this device; peer average 3.3/device2019-02: 0 reports for this device; peer average 2.87/device2019-03: 0 reports for this device; peer average 3.14/device2019-04: 0 reports for this device; peer average 3.04/device2019-05: 2 reports for this device; peer average 2.18/device2019-06: 2 reports for this device; peer average 1.9/device2019-07: 0 reports for this device; peer average 1.93/device2019-08: 2 reports for this device; peer average 2.5/device2019-09: 4 reports for this device; peer average 2.39/device2019-10: 8 reports for this device; peer average 2.99/device2019-11: 0 reports for this device; peer average 2.43/device2019-12: 3 reports for this device; peer average 2.67/device2020-01: 0 reports for this device; peer average 3.26/device2020-02: 3 reports for this device; peer average 3.36/device2020-03: 6 reports for this device; peer average 3.87/device2020-04: 3 reports for this device; peer average 2.46/device2020-05: 1 reports for this device; peer average 2.45/device2020-06: 0 reports for this device; peer average 2.2/device2020-07: 0 reports for this device; peer average 3.09/device2020-08: 3 reports for this device; peer average 2.39/device2020-09: 6 reports for this device; peer average 2.95/device2020-10: 0 reports for this device; peer average 2.86/device2020-11: 3 reports for this device; peer average 2.54/device2020-12: 3 reports for this device; peer average 3.02/device2021-01: 0 reports for this device; peer average 2.81/device2021-02: 0 reports for this device; peer average 2.68/device2021-03: 3 reports for this device; peer average 2.63/device2021-04: 0 reports for this device; peer average 2.66/device2021-05: 0 reports for this device; peer average 2.3/device2021-06: 0 reports for this device; peer average 3.32/device2021-07: 6 reports for this device; peer average 3.33/device2021-08: 0 reports for this device; peer average 3.18/device2021-09: 0 reports for this device; peer average 3.13/device2021-10: 0 reports for this device; peer average 2.79/device2021-11: 0 reports for this device; peer average 2.47/device2021-12: 0 reports for this device; peer average 2.7/device2022-01: 0 reports for this device; peer average 2.37/device2022-02: 6 reports for this device; peer average 2.61/device2022-03: 0 reports for this device; peer average 3.01/device2022-04: 3 reports for this device; peer average 2.69/device2022-05: 0 reports for this device; peer average 2.78/device2022-06: 0 reports for this device; peer average 2.79/device2022-07: 0 reports for this device; peer average 2.94/device2022-08: 3 reports for this device; peer average 3.11/device2022-09: 0 reports for this device; peer average 2.97/device2022-10: 0 reports for this device; peer average 3.16/device2022-11: 0 reports for this device; peer average 2.83/device2022-12: 0 reports for this device; peer average 2.95/device2023-01: 0 reports for this device; peer average 3.46/device2023-02: 2 reports for this device; peer average 3/device2023-03: 0 reports for this device; peer average 3.15/device2023-04: 0 reports for this device; peer average 3.03/device2023-05: 0 reports for this device; peer average 3.01/device2023-06: 3 reports for this device; peer average 3.27/device2023-07: 0 reports for this device; peer average 3.02/device2023-08: 0 reports for this device; peer average 2.9/device2023-09: 0 reports for this device; peer average 2.88/device2023-10: 3 reports for this device; peer average 2.35/device2023-11: 3 reports for this device; peer average 2.42/device2023-12: 0 reports for this device; peer average 2.67/device2024-01: 0 reports for this device; peer average 2.49/device2024-02: 0 reports for this device; peer average 2.6/device2024-03: 3 reports for this device; peer average 2.64/device2024-04: 0 reports for this device; peer average 2.36/device2024-05: 0 reports for this device; peer average 3.45/device2024-06: 6 reports for this device; peer average 2.87/device2024-07: 0 reports for this device; peer average 2.39/device2024-08: 0 reports for this device; peer average 2.92/device2024-09: 0 reports for this device; peer average 3.17/device2024-10: 0 reports for this device; peer average 2.58/device2024-11: 0 reports for this device; peer average 2.41/device2024-12: 0 reports for this device; peer average 2.15/device2025-01: 0 reports for this device; peer average 2.41/device2025-02: 2 reports for this device; peer average 1.82/device2025-03: 0 reports for this device; peer average 2.21/device2025-04: 2 reports for this device; peer average 2.48/device2025-05: 0 reports for this device; peer average 2.34/device2025-06: 2 reports for this device; peer average 2.28/device2025-07: 0 reports for this device; peer average 2.49/device2025-08: 0 reports for this device; peer average 2.47/device2025-09: 0 reports for this device; peer average 2.18/device2025-10: 2 reports for this device; peer average 2.31/device2025-11: 4 reports for this device; peer average 2.09/device2025-12: 0 reports for this device; peer average 2.23/device2026-01: 0 reports for this device; peer average 2.25/device2026-02: 0 reports for this device; peer average 2.22/device2026-03: 0 reports for this device; peer average 2.35/device2026-04: 0 reports for this device; peer average 2.34/device2026-05: 0 reports for this device; peer average 2.07/device2026-06: 0 reports for this device; peer average 2.38/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0103.3
2019-0202.87
2019-0303.14
2019-0403.04
2019-0522.18
2019-0621.9
2019-0701.93
2019-0822.5
2019-0942.39
2019-1082.99
2019-1102.43
2019-1232.67
2020-0103.26
2020-0233.36
2020-0363.87
2020-0432.46
2020-0512.45
2020-0602.2
2020-0703.09
2020-0832.39
2020-0962.95
2020-1002.86
2020-1132.54
2020-1233.02
2021-0102.81
2021-0202.68
2021-0332.63
2021-0402.66
2021-0502.3
2021-0603.32
2021-0763.33
2021-0803.18
2021-0903.13
2021-1002.79
2021-1102.47
2021-1202.7
2022-0102.37
2022-0262.61
2022-0303.01
2022-0432.69
2022-0502.78
2022-0602.79
2022-0702.94
2022-0833.11
2022-0902.97
2022-1003.16
2022-1102.83
2022-1202.95
2023-0103.46
2023-0223
2023-0303.15
2023-0403.03
2023-0503.01
2023-0633.27
2023-0703.02
2023-0802.9
2023-0902.88
2023-1032.35
2023-1132.42
2023-1202.67
2024-0102.49
2024-0202.6
2024-0332.64
2024-0402.36
2024-0503.45
2024-0662.87
2024-0702.39
2024-0802.92
2024-0903.17
2024-1002.58
2024-1102.41
2024-1202.15
2025-0102.41
2025-0221.82
2025-0302.21
2025-0422.48
2025-0502.34
2025-0622.28
2025-0702.49
2025-0802.47
2025-0902.18
2025-1022.31
2025-1142.09
2025-1202.23
2026-0102.25
2026-0202.22
2026-0302.35
2026-0402.34
2026-0502.07
2026-0602.38
This device (reports/month)Average device in LWJ, MRA (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
2025-11-243010536692-2025-00375InjuryAvailablecatalog number
2025-11-243010536692-2025-00374InjuryAvailablecatalog number
2025-10-273010536692-2025-00354InjuryAvailablecatalog number
2025-06-023010536692-2025-00272InjuryAvailablecatalog number
2025-04-233010536692-2025-00174InjuryAvailablecatalog number
2025-02-063010536692-2025-00043InjuryAvailablecatalog number
2024-06-213010536692-2024-00368InjuryAvailablecatalog number
2024-06-183010536692-2024-00348InjuryAvailablecatalog number
2024-03-053010536692-2024-00124InjuryAvailablecatalog number
2023-11-283010536692-2023-00219InjuryAvailablecatalog number
2023-10-233010536692-2023-00192MalfunctionAvailablecatalog number
2023-06-013010536692-2023-00104InjuryAvailablecatalog number
2023-02-153010536692-2023-00020InjuryAvailablecatalog number
2022-08-293010536692-2022-00298InjuryAvailablecatalog number
2022-04-063010536692-2022-00102InjuryAvailablecatalog number

Showing the most recent 41 of 102 linked reports.

Showing 1–15 of 41
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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