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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.

3 linked reportsMalfunction 2Injury 1
5914182019-01: 0 reports for this device; peer average 1.89/device2019-02: 0 reports for this device; peer average 1.38/device2019-03: 0 reports for this device; peer average 1.4/device2019-04: 0 reports for this device; peer average 1.43/device2019-05: 0 reports for this device; peer average 3/device2019-06: 0 reports for this device; peer average 3.23/device2019-07: 0 reports for this device; peer average 1.94/device2019-08: 0 reports for this device; peer average 4.47/device2019-09: 0 reports for this device; peer average 3.44/device2019-10: 0 reports for this device; peer average 3.31/device2019-11: 0 reports for this device; peer average 3.76/device2019-12: 0 reports for this device; peer average 4.07/device2020-01: 0 reports for this device; peer average 3.07/device2020-02: 0 reports for this device; peer average 3.11/device2020-03: 0 reports for this device; peer average 1.81/device2020-04: 0 reports for this device; peer average 1.35/device2020-05: 0 reports for this device; peer average 3.36/device2020-06: 0 reports for this device; peer average 1.4/device2020-07: 0 reports for this device; peer average 1.68/device2020-08: 0 reports for this device; peer average 2.89/device2020-09: 0 reports for this device; peer average 2.24/device2020-10: 0 reports for this device; peer average 2.91/device2020-11: 0 reports for this device; peer average 4.03/device2020-12: 0 reports for this device; peer average 4.95/device2021-01: 0 reports for this device; peer average 2.56/device2021-02: 0 reports for this device; peer average 3.25/device2021-03: 0 reports for this device; peer average 7.58/device2021-04: 0 reports for this device; peer average 6.11/device2021-05: 0 reports for this device; peer average 2.96/device2021-06: 0 reports for this device; peer average 10.58/device2021-07: 0 reports for this device; peer average 9.17/device2021-08: 0 reports for this device; peer average 6.3/device2021-09: 0 reports for this device; peer average 2.95/device2021-10: 0 reports for this device; peer average 7.23/device2021-11: 0 reports for this device; peer average 8.37/device2021-12: 0 reports for this device; peer average 5.81/device2022-01: 0 reports for this device; peer average 5.88/device2022-02: 0 reports for this device; peer average 4.1/device2022-03: 0 reports for this device; peer average 5.24/device2022-04: 0 reports for this device; peer average 2.56/device2022-05: 0 reports for this device; peer average 5.49/device2022-06: 0 reports for this device; peer average 3.81/device2022-07: 0 reports for this device; peer average 4.41/device2022-08: 0 reports for this device; peer average 4.51/device2022-09: 0 reports for this device; peer average 7.54/device2022-10: 0 reports for this device; peer average 6.75/device2022-11: 0 reports for this device; peer average 10/device2022-12: 0 reports for this device; peer average 3.91/device2023-01: 0 reports for this device; peer average 9.76/device2023-02: 0 reports for this device; peer average 5.79/device2023-03: 0 reports for this device; peer average 3.53/device2023-04: 0 reports for this device; peer average 2.84/device2023-05: 0 reports for this device; peer average 6.33/device2023-06: 0 reports for this device; peer average 7.64/device2023-07: 0 reports for this device; peer average 6/device2023-08: 0 reports for this device; peer average 10.31/device2023-09: 0 reports for this device; peer average 7.81/device2023-10: 0 reports for this device; peer average 7.13/device2023-11: 0 reports for this device; peer average 6.86/device2023-12: 0 reports for this device; peer average 4.27/device2024-01: 0 reports for this device; peer average 5.94/device2024-02: 0 reports for this device; peer average 18.12/device2024-03: 0 reports for this device; peer average 5.54/device2024-04: 0 reports for this device; peer average 9.95/device2024-05: 1 reports for this device; peer average 11.78/device2024-06: 1 reports for this device; peer average 6.74/device2024-07: 1 reports for this device; peer average 5.2/device2024-08: 0 reports for this device; peer average 4.32/device2024-09: 0 reports for this device; peer average 4.81/device2024-10: 0 reports for this device; peer average 2.9/device2024-11: 0 reports for this device; peer average 3.09/device2024-12: 0 reports for this device; peer average 2/device2025-01: 0 reports for this device; peer average 1.71/device2025-02: 0 reports for this device; peer average 1.29/device2025-03: 0 reports for this device; peer average 4/device2025-04: 0 reports for this device; peer average 1.28/device2025-05: 0 reports for this device; peer average 1.96/device2025-06: 0 reports for this device; peer average 2/device2025-07: 0 reports for this device; peer average 7.04/device2025-08: 0 reports for this device; peer average 2.79/device2025-09: 0 reports for this device; peer average 1.11/device2025-10: 0 reports for this device; peer average 1/device2025-11: 0 reports for this device; peer average 1.16/device2025-12: 0 reports for this device; peer average 1.74/device2026-01: 0 reports for this device; peer average 4.21/device2026-02: 0 reports for this device; peer average 2.52/device2026-03: 0 reports for this device; peer average 1.65/device2026-04: 0 reports for this device; peer average 13.87/device2026-05: 0 reports for this device; peer average 1.4/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)
2019-0101.89
2019-0201.38
2019-0301.4
2019-0401.43
2019-0503
2019-0603.23
2019-0701.94
2019-0804.47
2019-0903.44
2019-1003.31
2019-1103.76
2019-1204.07
2020-0103.07
2020-0203.11
2020-0301.81
2020-0401.35
2020-0503.36
2020-0601.4
2020-0701.68
2020-0802.89
2020-0902.24
2020-1002.91
2020-1104.03
2020-1204.95
2021-0102.56
2021-0203.25
2021-0307.58
2021-0406.11
2021-0502.96
2021-06010.58
2021-0709.17
2021-0806.3
2021-0902.95
2021-1007.23
2021-1108.37
2021-1205.81
2022-0105.88
2022-0204.1
2022-0305.24
2022-0402.56
2022-0505.49
2022-0603.81
2022-0704.41
2022-0804.51
2022-0907.54
2022-1006.75
2022-11010
2022-1203.91
2023-0109.76
2023-0205.79
2023-0303.53
2023-0402.84
2023-0506.33
2023-0607.64
2023-0706
2023-08010.31
2023-0907.81
2023-1007.13
2023-1106.86
2023-1204.27
2024-0105.94
2024-02018.12
2024-0305.54
2024-0409.95
2024-05111.78
2024-0616.74
2024-0715.2
2024-0804.32
2024-0904.81
2024-1002.9
2024-1103.09
2024-1202
2025-0101.71
2025-0201.29
2025-0304
2025-0401.28
2025-0501.96
2025-0602
2025-0707.04
2025-0802.79
2025-0901.11
2025-1001
2025-1101.16
2025-1201.74
2026-0104.21
2026-0202.52
2026-0301.65
2026-04013.87
2026-0501.4
2026-0601.95
This device (reports/month)Average device in HTO (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2024-07-189681642-2024-00025MalfunctionAvailableexact di
2024-06-269681642-2024-00024MalfunctionAvailableexact di
2024-05-173009760038-2024-00025InjuryAvailableexact di
Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2026-03-12VAIVoluntary action indicatedUnited Orthopedic Corp.0
2026-03-12VAIVoluntary action indicatedUnited Orthopedic Corp.0
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