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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
25792019-01: 0 reports for this device; peer average 3.32/device2019-02: 0 reports for this device; peer average 2.85/device2019-03: 0 reports for this device; peer average 3.29/device2019-04: 0 reports for this device; peer average 3.04/device2019-05: 0 reports for this device; peer average 2.32/device2019-06: 3 reports for this device; peer average 2/device2019-07: 3 reports for this device; peer average 1.96/device2019-08: 0 reports for this device; peer average 2.36/device2019-09: 0 reports for this device; peer average 2.66/device2019-10: 0 reports for this device; peer average 2.96/device2019-11: 0 reports for this device; peer average 2.47/device2019-12: 0 reports for this device; peer average 2.82/device2020-01: 0 reports for this device; peer average 3.31/device2020-02: 0 reports for this device; peer average 2.83/device2020-03: 0 reports for this device; peer average 3.61/device2020-04: 0 reports for this device; peer average 2.56/device2020-05: 0 reports for this device; peer average 2.44/device2020-06: 0 reports for this device; peer average 2.36/device2020-07: 9 reports for this device; peer average 2.82/device2020-08: 0 reports for this device; peer average 2.3/device2020-09: 0 reports for this device; peer average 2.95/device2020-10: 0 reports for this device; peer average 2.92/device2020-11: 0 reports for this device; peer average 2.64/device2020-12: 0 reports for this device; peer average 2.63/device2021-01: 0 reports for this device; peer average 2.79/device2021-02: 3 reports for this device; peer average 2.32/device2021-03: 0 reports for this device; peer average 2.31/device2021-04: 0 reports for this device; peer average 2.35/device2021-05: 0 reports for this device; peer average 2.23/device2021-06: 0 reports for this device; peer average 2.8/device2021-07: 0 reports for this device; peer average 2.65/device2021-08: 0 reports for this device; peer average 2.71/device2021-09: 0 reports for this device; peer average 2.78/device2021-10: 0 reports for this device; peer average 2.48/device2021-11: 0 reports for this device; peer average 2.34/device2021-12: 3 reports for this device; peer average 2.62/device2022-01: 3 reports for this device; peer average 2.39/device2022-02: 0 reports for this device; peer average 2.25/device2022-03: 0 reports for this device; peer average 2.54/device2022-04: 0 reports for this device; peer average 2.4/device2022-05: 0 reports for this device; peer average 2.42/device2022-06: 0 reports for this device; peer average 2.54/device2022-07: 0 reports for this device; peer average 2.37/device2022-08: 0 reports for this device; peer average 2.43/device2022-09: 0 reports for this device; peer average 2.47/device2022-10: 0 reports for this device; peer average 2.44/device2022-11: 3 reports for this device; peer average 2.52/device2022-12: 0 reports for this device; peer average 2.56/device2023-01: 0 reports for this device; peer average 2.65/device2023-02: 0 reports for this device; peer average 2.47/device2023-03: 0 reports for this device; peer average 2.74/device2023-04: 0 reports for this device; peer average 2.58/device2023-05: 0 reports for this device; peer average 2.46/device2023-06: 0 reports for this device; peer average 2.54/device2023-07: 0 reports for this device; peer average 2.32/device2023-08: 0 reports for this device; peer average 2.11/device2023-09: 0 reports for this device; peer average 2.09/device2023-10: 0 reports for this device; peer average 1.86/device2023-11: 0 reports for this device; peer average 1.79/device2023-12: 0 reports for this device; peer average 1.91/device2024-01: 0 reports for this device; peer average 1.89/device2024-02: 6 reports for this device; peer average 2.28/device2024-03: 0 reports for this device; peer average 2.07/device2024-04: 0 reports for this device; peer average 1.92/device2024-05: 0 reports for this device; peer average 2.2/device2024-06: 0 reports for this device; peer average 2.04/device2024-07: 0 reports for this device; peer average 1.86/device2024-08: 0 reports for this device; peer average 2.02/device2024-09: 0 reports for this device; peer average 2.19/device2024-10: 0 reports for this device; peer average 1.94/device2024-11: 0 reports for this device; peer average 2/device2024-12: 0 reports for this device; peer average 1.69/device2025-01: 0 reports for this device; peer average 2.18/device2025-02: 3 reports for this device; peer average 1.66/device2025-03: 0 reports for this device; peer average 1.88/device2025-04: 0 reports for this device; peer average 1.93/device2025-05: 0 reports for this device; peer average 1.93/device2025-06: 0 reports for this device; peer average 1.97/device2025-07: 0 reports for this device; peer average 1.96/device2025-08: 0 reports for this device; peer average 1.9/device2025-09: 0 reports for this device; peer average 1.82/device2025-10: 0 reports for this device; peer average 1.83/device2025-11: 0 reports for this device; peer average 1.88/device2025-12: 0 reports for this device; peer average 2/device2026-01: 0 reports for this device; peer average 2.06/device2026-02: 0 reports for this device; peer average 1.78/device2026-03: 0 reports for this device; peer average 2.01/device2026-04: 0 reports for this device; peer average 2.03/device2026-05: 0 reports for this device; peer average 1.84/device2026-06: 0 reports for this device; peer average 1.87/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0103.32
2019-0202.85
2019-0303.29
2019-0403.04
2019-0502.32
2019-0632
2019-0731.96
2019-0802.36
2019-0902.66
2019-1002.96
2019-1102.47
2019-1202.82
2020-0103.31
2020-0202.83
2020-0303.61
2020-0402.56
2020-0502.44
2020-0602.36
2020-0792.82
2020-0802.3
2020-0902.95
2020-1002.92
2020-1102.64
2020-1202.63
2021-0102.79
2021-0232.32
2021-0302.31
2021-0402.35
2021-0502.23
2021-0602.8
2021-0702.65
2021-0802.71
2021-0902.78
2021-1002.48
2021-1102.34
2021-1232.62
2022-0132.39
2022-0202.25
2022-0302.54
2022-0402.4
2022-0502.42
2022-0602.54
2022-0702.37
2022-0802.43
2022-0902.47
2022-1002.44
2022-1132.52
2022-1202.56
2023-0102.65
2023-0202.47
2023-0302.74
2023-0402.58
2023-0502.46
2023-0602.54
2023-0702.32
2023-0802.11
2023-0902.09
2023-1001.86
2023-1101.79
2023-1201.91
2024-0101.89
2024-0262.28
2024-0302.07
2024-0401.92
2024-0502.2
2024-0602.04
2024-0701.86
2024-0802.02
2024-0902.19
2024-1001.94
2024-1102
2024-1201.69
2025-0102.18
2025-0231.66
2025-0301.88
2025-0401.93
2025-0501.93
2025-0601.97
2025-0701.96
2025-0801.9
2025-0901.82
2025-1001.83
2025-1101.88
2025-1202
2026-0102.06
2026-0201.78
2026-0302.01
2026-0402.03
2026-0501.84
2026-0601.87
This device (reports/month)Average device in LPH, LZO (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
2025-02-063010536692-2025-00039InjuryAvailablecatalog number
2024-02-273010536692-2024-00104InjuryAvailablecatalog number
2024-02-213010536692-2024-00088InjuryAvailablecatalog number
2022-11-073010536692-2022-00403InjuryAvailablecatalog number
2022-01-043010536692-2022-00003InjuryAvailablecatalog number
2021-12-283010536692-2021-00601InjuryAvailablecatalog number
2021-02-013010536692-2021-00049InjuryAvailablecatalog number
2020-07-313010536692-2020-00538InjuryAvailablecatalog number
2020-07-293010536692-2020-00524InjuryAvailablecatalog number
2020-07-163010536692-2020-00490InjuryAvailablecatalog number
2019-07-183010536692-2019-00903InjuryAvailablecatalog number
2019-06-243010536692-2019-00831InjuryAvailablecatalog 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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