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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 reportsMalfunction 36
5914192019-01: 0 reports for this device; peer average 9.11/device2019-02: 1 reports for this device; peer average 9.71/device2019-03: 2 reports for this device; peer average 9.79/device2019-04: 0 reports for this device; peer average 11.87/device2019-05: 1 reports for this device; peer average 13.04/device2019-06: 1 reports for this device; peer average 13.02/device2019-07: 0 reports for this device; peer average 9.88/device2019-08: 1 reports for this device; peer average 7.49/device2019-09: 0 reports for this device; peer average 7.85/device2019-10: 2 reports for this device; peer average 7.27/device2019-11: 1 reports for this device; peer average 9.91/device2019-12: 1 reports for this device; peer average 10.08/device2020-01: 1 reports for this device; peer average 8.04/device2020-02: 0 reports for this device; peer average 9.15/device2020-03: 0 reports for this device; peer average 9.62/device2020-04: 0 reports for this device; peer average 9.53/device2020-05: 0 reports for this device; peer average 11.43/device2020-06: 0 reports for this device; peer average 8.71/device2020-07: 0 reports for this device; peer average 9.7/device2020-08: 0 reports for this device; peer average 8.58/device2020-09: 0 reports for this device; peer average 8.91/device2020-10: 0 reports for this device; peer average 9.9/device2020-11: 0 reports for this device; peer average 10.94/device2020-12: 0 reports for this device; peer average 9.27/device2021-01: 0 reports for this device; peer average 9.05/device2021-02: 0 reports for this device; peer average 9.77/device2021-03: 0 reports for this device; peer average 9.35/device2021-04: 0 reports for this device; peer average 8.9/device2021-05: 1 reports for this device; peer average 9.8/device2021-06: 0 reports for this device; peer average 11.37/device2021-07: 0 reports for this device; peer average 8.74/device2021-08: 0 reports for this device; peer average 10.53/device2021-09: 0 reports for this device; peer average 13/device2021-10: 0 reports for this device; peer average 8.34/device2021-11: 0 reports for this device; peer average 11.01/device2021-12: 1 reports for this device; peer average 7.44/device2022-01: 0 reports for this device; peer average 6.82/device2022-02: 0 reports for this device; peer average 7.95/device2022-03: 0 reports for this device; peer average 9.35/device2022-04: 0 reports for this device; peer average 6.39/device2022-05: 1 reports for this device; peer average 8.87/device2022-06: 0 reports for this device; peer average 9.36/device2022-07: 1 reports for this device; peer average 8.79/device2022-08: 0 reports for this device; peer average 8.72/device2022-09: 0 reports for this device; peer average 8.74/device2022-10: 1 reports for this device; peer average 11.56/device2022-11: 1 reports for this device; peer average 10.32/device2022-12: 2 reports for this device; peer average 10.44/device2023-01: 1 reports for this device; peer average 9.14/device2023-02: 0 reports for this device; peer average 8.45/device2023-03: 0 reports for this device; peer average 10.04/device2023-04: 1 reports for this device; peer average 10.25/device2023-05: 1 reports for this device; peer average 10.82/device2023-06: 1 reports for this device; peer average 12.34/device2023-07: 1 reports for this device; peer average 14.14/device2023-08: 1 reports for this device; peer average 13.16/device2023-09: 2 reports for this device; peer average 11.4/device2023-10: 2 reports for this device; peer average 10.8/device2023-11: 1 reports for this device; peer average 14.61/device2023-12: 2 reports for this device; peer average 12.27/device2024-01: 0 reports for this device; peer average 16.51/device2024-02: 0 reports for this device; peer average 12.43/device2024-03: 0 reports for this device; peer average 14.98/device2024-04: 0 reports for this device; peer average 13.44/device2024-05: 1 reports for this device; peer average 12.95/device2024-06: 0 reports for this device; peer average 12.52/device2024-07: 1 reports for this device; peer average 13.91/device2024-08: 1 reports for this device; peer average 18.98/device2024-09: 0 reports for this device; peer average 14.7/device2024-10: 1 reports for this device; peer average 18.36/device2024-11: 0 reports for this device; peer average 10.72/device2024-12: 0 reports for this device; peer average 10.63/device2025-01: 0 reports for this device; peer average 12.32/device2025-02: 0 reports for this device; peer average 13.73/device2025-03: 0 reports for this device; peer average 12.56/device2025-04: 0 reports for this device; peer average 13.77/device2025-05: 0 reports for this device; peer average 13.22/device2025-06: 0 reports for this device; peer average 16.69/device2025-07: 0 reports for this device; peer average 12.44/device2025-08: 0 reports for this device; peer average 10.63/device2025-09: 0 reports for this device; peer average 11.02/device2025-10: 0 reports for this device; peer average 10.7/device2025-11: 0 reports for this device; peer average 9.45/device2025-12: 0 reports for this device; peer average 8.85/device2026-01: 0 reports for this device; peer average 10.24/device2026-02: 0 reports for this device; peer average 8.24/device2026-03: 0 reports for this device; peer average 8.88/device2026-04: 0 reports for this device; peer average 7.34/device2026-05: 0 reports for this device; peer average 7.59/device2026-06: 0 reports for this device; peer average 5.85/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0109.11
2019-0219.71
2019-0329.79
2019-04011.87
2019-05113.04
2019-06113.02
2019-0709.88
2019-0817.49
2019-0907.85
2019-1027.27
2019-1119.91
2019-12110.08
2020-0118.04
2020-0209.15
2020-0309.62
2020-0409.53
2020-05011.43
2020-0608.71
2020-0709.7
2020-0808.58
2020-0908.91
2020-1009.9
2020-11010.94
2020-1209.27
2021-0109.05
2021-0209.77
2021-0309.35
2021-0408.9
2021-0519.8
2021-06011.37
2021-0708.74
2021-08010.53
2021-09013
2021-1008.34
2021-11011.01
2021-1217.44
2022-0106.82
2022-0207.95
2022-0309.35
2022-0406.39
2022-0518.87
2022-0609.36
2022-0718.79
2022-0808.72
2022-0908.74
2022-10111.56
2022-11110.32
2022-12210.44
2023-0119.14
2023-0208.45
2023-03010.04
2023-04110.25
2023-05110.82
2023-06112.34
2023-07114.14
2023-08113.16
2023-09211.4
2023-10210.8
2023-11114.61
2023-12212.27
2024-01016.51
2024-02012.43
2024-03014.98
2024-04013.44
2024-05112.95
2024-06012.52
2024-07113.91
2024-08118.98
2024-09014.7
2024-10118.36
2024-11010.72
2024-12010.63
2025-01012.32
2025-02013.73
2025-03012.56
2025-04013.77
2025-05013.22
2025-06016.69
2025-07012.44
2025-08010.63
2025-09011.02
2025-10010.7
2025-1109.45
2025-1208.85
2026-01010.24
2026-0208.24
2026-0308.88
2026-0407.34
2026-0507.59
2026-0605.85
This device (reports/month)Average device in HAW, OLO (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
2024-10-030008010177-2024-00106MalfunctionAvailableexact di
2024-08-070008010177-2024-00078MalfunctionAvailableexact di
2024-07-010008010177-2024-00056MalfunctionAvailableexact di
2024-05-210008010177-2024-00047MalfunctionAvailableexact di
2023-12-283015967359-2023-02663MalfunctionAvailableexact di
2023-12-123015967359-2023-02585MalfunctionAvailableexact di
2023-11-273015967359-2023-02506MalfunctionAvailableexact di
2023-10-233015967359-2023-02150MalfunctionAvailableexact di
2023-10-233015967359-2023-02149MalfunctionAvailableexact di
2023-09-253015967359-2023-02004MalfunctionAvailableexact di
2023-09-193015967359-2023-01971MalfunctionAvailableexact di
2023-08-283015967359-2023-01909MalfunctionAvailableexact di
2023-07-173015967359-2023-01454MalfunctionAvailableexact di
2023-06-283015967359-2023-01381MalfunctionAvailableexact di
2023-05-303015967359-2023-01205MalfunctionAvailableexact di
Showing 1–15 of 36
Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2025-02-27NAINo action indicatedStryker Leibinger GmbH & Co. KG0
2017-07-27NAINo action indicatedStryker Leibinger GmbH & Co. KG0
2013-11-14NAINo action indicatedStryker Leibinger GmbH & Co. KG0
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