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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.

36 linked reportsInjury 36
23562019-01: 0 reports for this device; peer average 4.85/device2019-02: 0 reports for this device; peer average 3.81/device2019-03: 0 reports for this device; peer average 4.74/device2019-04: 0 reports for this device; peer average 3.37/device2019-05: 0 reports for this device; peer average 3.42/device2019-06: 0 reports for this device; peer average 2.95/device2019-07: 0 reports for this device; peer average 2.91/device2019-08: 0 reports for this device; peer average 2.95/device2019-09: 3 reports for this device; peer average 3.5/device2019-10: 3 reports for this device; peer average 4.54/device2019-11: 0 reports for this device; peer average 2.57/device2019-12: 0 reports for this device; peer average 3.73/device2020-01: 3 reports for this device; peer average 2.89/device2020-02: 0 reports for this device; peer average 2.8/device2020-03: 3 reports for this device; peer average 3.42/device2020-04: 0 reports for this device; peer average 2.69/device2020-05: 0 reports for this device; peer average 2.61/device2020-06: 0 reports for this device; peer average 1.86/device2020-07: 0 reports for this device; peer average 2.29/device2020-08: 0 reports for this device; peer average 2.53/device2020-09: 3 reports for this device; peer average 3.7/device2020-10: 3 reports for this device; peer average 2.18/device2020-11: 0 reports for this device; peer average 2.77/device2020-12: 0 reports for this device; peer average 2.85/device2021-01: 0 reports for this device; peer average 2.95/device2021-02: 0 reports for this device; peer average 2.8/device2021-03: 0 reports for this device; peer average 2.08/device2021-04: 0 reports for this device; peer average 2.43/device2021-05: 0 reports for this device; peer average 2/device2021-06: 0 reports for this device; peer average 2.63/device2021-07: 0 reports for this device; peer average 3.2/device2021-08: 3 reports for this device; peer average 2.71/device2021-09: 3 reports for this device; peer average 2.5/device2021-10: 0 reports for this device; peer average 2.37/device2021-11: 0 reports for this device; peer average 1.83/device2021-12: 6 reports for this device; peer average 3.71/device2022-01: 0 reports for this device; peer average 2.55/device2022-02: 0 reports for this device; peer average 1.73/device2022-03: 0 reports for this device; peer average 2.59/device2022-04: 0 reports for this device; peer average 2.1/device2022-05: 0 reports for this device; peer average 2.47/device2022-06: 0 reports for this device; peer average 2.48/device2022-07: 0 reports for this device; peer average 1.95/device2022-08: 0 reports for this device; peer average 1.9/device2022-09: 0 reports for this device; peer average 2.4/device2022-10: 0 reports for this device; peer average 1.43/device2022-11: 0 reports for this device; peer average 1.71/device2022-12: 0 reports for this device; peer average 2.1/device2023-01: 0 reports for this device; peer average 2.36/device2023-02: 3 reports for this device; peer average 2.03/device2023-03: 0 reports for this device; peer average 3/device2023-04: 0 reports for this device; peer average 2.64/device2023-05: 0 reports for this device; peer average 2.08/device2023-06: 0 reports for this device; peer average 3.11/device2023-07: 0 reports for this device; peer average 1.78/device2023-08: 0 reports for this device; peer average 2.16/device2023-09: 3 reports for this device; peer average 3.18/device2023-10: 0 reports for this device; peer average 2.35/device2023-11: 0 reports for this device; peer average 2.19/device2023-12: 0 reports for this device; peer average 2.55/device2024-01: 0 reports for this device; peer average 2.07/device2024-02: 0 reports for this device; peer average 3.43/device2024-03: 0 reports for this device; peer average 1.64/device2024-04: 0 reports for this device; peer average 1.93/device2024-05: 0 reports for this device; peer average 1.86/device2024-06: 0 reports for this device; peer average 1.9/device2024-07: 0 reports for this device; peer average 1.9/device2024-08: 0 reports for this device; peer average 1.31/device2024-09: 0 reports for this device; peer average 1.64/device2024-10: 0 reports for this device; peer average 1.8/device2024-11: 0 reports for this device; peer average 1.9/device2024-12: 0 reports for this device; peer average 1.78/device2025-01: 0 reports for this device; peer average 2.64/device2025-02: 0 reports for this device; peer average 1.9/device2025-03: 0 reports for this device; peer average 2.39/device2025-04: 0 reports for this device; peer average 2.23/device2025-05: 0 reports for this device; peer average 2.08/device2025-06: 0 reports for this device; peer average 2.1/device2025-07: 0 reports for this device; peer average 2.17/device2025-08: 0 reports for this device; peer average 1.63/device2025-09: 0 reports for this device; peer average 2.05/device2025-10: 0 reports for this device; peer average 1.63/device2025-11: 0 reports for this device; peer average 1.76/device2025-12: 0 reports for this device; peer average 2.44/device2026-01: 0 reports for this device; peer average 2.68/device2026-02: 0 reports for this device; peer average 2.03/device2026-03: 0 reports for this device; peer average 2.18/device2026-04: 0 reports for this device; peer average 1.94/device2026-05: 0 reports for this device; peer average 1.68/device2026-06: 0 reports for this device; peer average 1.95/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0104.85
2019-0203.81
2019-0304.74
2019-0403.37
2019-0503.42
2019-0602.95
2019-0702.91
2019-0802.95
2019-0933.5
2019-1034.54
2019-1102.57
2019-1203.73
2020-0132.89
2020-0202.8
2020-0333.42
2020-0402.69
2020-0502.61
2020-0601.86
2020-0702.29
2020-0802.53
2020-0933.7
2020-1032.18
2020-1102.77
2020-1202.85
2021-0102.95
2021-0202.8
2021-0302.08
2021-0402.43
2021-0502
2021-0602.63
2021-0703.2
2021-0832.71
2021-0932.5
2021-1002.37
2021-1101.83
2021-1263.71
2022-0102.55
2022-0201.73
2022-0302.59
2022-0402.1
2022-0502.47
2022-0602.48
2022-0701.95
2022-0801.9
2022-0902.4
2022-1001.43
2022-1101.71
2022-1202.1
2023-0102.36
2023-0232.03
2023-0303
2023-0402.64
2023-0502.08
2023-0603.11
2023-0701.78
2023-0802.16
2023-0933.18
2023-1002.35
2023-1102.19
2023-1202.55
2024-0102.07
2024-0203.43
2024-0301.64
2024-0401.93
2024-0501.86
2024-0601.9
2024-0701.9
2024-0801.31
2024-0901.64
2024-1001.8
2024-1101.9
2024-1201.78
2025-0102.64
2025-0201.9
2025-0302.39
2025-0402.23
2025-0502.08
2025-0602.1
2025-0702.17
2025-0801.63
2025-0902.05
2025-1001.63
2025-1101.76
2025-1202.44
2026-0102.68
2026-0202.03
2026-0302.18
2026-0401.94
2026-0501.68
2026-0601.95
This device (reports/month)Average device in JDL, KWA (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2023-09-133010536692-2023-00161InjuryAvailablecatalog number
2023-02-153010536692-2023-00024InjuryAvailablecatalog number
2021-12-293010536692-2021-00610InjuryAvailablecatalog number
2021-12-213010536692-2021-00594InjuryAvailablecatalog number
2021-09-213010536692-2021-00524InjuryAvailablecatalog number
2021-08-303010536692-2021-00457InjuryAvailablecatalog number
2020-10-283010536692-2020-00668InjuryAvailablecatalog number
2020-09-013010536692-2020-00595InjuryAvailablecatalog number
2020-03-043010536692-2020-00189InjuryAvailablecatalog number
2020-01-063010536692-2020-00018InjuryAvailablecatalog number
2019-10-113010536692-2019-01087InjuryAvailablecatalog number
2019-09-183010536692-2019-01039InjuryAvailablecatalog number

Showing the most recent 12 of 36 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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