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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.

47 linked reportsMalfunction 36Injury 11
183654722019-01: 0 reports for this device; peer average 6.09/device2019-02: 0 reports for this device; peer average 5.59/device2019-03: 0 reports for this device; peer average 6.19/device2019-04: 0 reports for this device; peer average 7.81/device2019-05: 0 reports for this device; peer average 6.19/device2019-06: 0 reports for this device; peer average 4/device2019-07: 0 reports for this device; peer average 6.26/device2019-08: 0 reports for this device; peer average 7.14/device2019-09: 0 reports for this device; peer average 8.45/device2019-10: 0 reports for this device; peer average 6.87/device2019-11: 0 reports for this device; peer average 8.74/device2019-12: 0 reports for this device; peer average 7.84/device2020-01: 1 reports for this device; peer average 7.88/device2020-02: 0 reports for this device; peer average 5.09/device2020-03: 0 reports for this device; peer average 11.85/device2020-04: 0 reports for this device; peer average 10.61/device2020-05: 0 reports for this device; peer average 8.36/device2020-06: 0 reports for this device; peer average 6.16/device2020-07: 0 reports for this device; peer average 7.48/device2020-08: 0 reports for this device; peer average 8.52/device2020-09: 0 reports for this device; peer average 7.38/device2020-10: 0 reports for this device; peer average 10/device2020-11: 1 reports for this device; peer average 11.68/device2020-12: 3 reports for this device; peer average 11.65/device2021-01: 0 reports for this device; peer average 15.59/device2021-02: 0 reports for this device; peer average 13.16/device2021-03: 0 reports for this device; peer average 9.9/device2021-04: 0 reports for this device; peer average 11.75/device2021-05: 0 reports for this device; peer average 9.33/device2021-06: 0 reports for this device; peer average 7.84/device2021-07: 0 reports for this device; peer average 12.05/device2021-08: 0 reports for this device; peer average 9.17/device2021-09: 0 reports for this device; peer average 9.29/device2021-10: 0 reports for this device; peer average 11.68/device2021-11: 3 reports for this device; peer average 9.78/device2021-12: 0 reports for this device; peer average 10/device2022-01: 0 reports for this device; peer average 7.76/device2022-02: 0 reports for this device; peer average 11.54/device2022-03: 0 reports for this device; peer average 10.67/device2022-04: 0 reports for this device; peer average 6.19/device2022-05: 0 reports for this device; peer average 8.31/device2022-06: 1 reports for this device; peer average 7.57/device2022-07: 2 reports for this device; peer average 6.16/device2022-08: 0 reports for this device; peer average 8.39/device2022-09: 3 reports for this device; peer average 6.64/device2022-10: 0 reports for this device; peer average 8.06/device2022-11: 4 reports for this device; peer average 11.06/device2022-12: 2 reports for this device; peer average 8.96/device2023-01: 3 reports for this device; peer average 11.86/device2023-02: 1 reports for this device; peer average 12.58/device2023-03: 1 reports for this device; peer average 14.73/device2023-04: 1 reports for this device; peer average 14.78/device2023-05: 0 reports for this device; peer average 13.18/device2023-06: 0 reports for this device; peer average 16.77/device2023-07: 3 reports for this device; peer average 17.81/device2023-08: 1 reports for this device; peer average 20.46/device2023-09: 0 reports for this device; peer average 13.43/device2023-10: 1 reports for this device; peer average 16.51/device2023-11: 2 reports for this device; peer average 9.24/device2023-12: 0 reports for this device; peer average 15.57/device2024-01: 0 reports for this device; peer average 10.25/device2024-02: 0 reports for this device; peer average 16.66/device2024-03: 2 reports for this device; peer average 40.35/device2024-04: 0 reports for this device; peer average 61.7/device2024-05: 0 reports for this device; peer average 72.31/device2024-06: 0 reports for this device; peer average 69.97/device2024-07: 0 reports for this device; peer average 55.17/device2024-08: 0 reports for this device; peer average 32.98/device2024-09: 1 reports for this device; peer average 28.96/device2024-10: 1 reports for this device; peer average 17.14/device2024-11: 0 reports for this device; peer average 15.37/device2024-12: 0 reports for this device; peer average 10.96/device2025-01: 0 reports for this device; peer average 8.77/device2025-02: 0 reports for this device; peer average 7.59/device2025-03: 0 reports for this device; peer average 7.76/device2025-04: 0 reports for this device; peer average 10.04/device2025-05: 0 reports for this device; peer average 12.83/device2025-06: 0 reports for this device; peer average 13.22/device2025-07: 0 reports for this device; peer average 7.86/device2025-08: 0 reports for this device; peer average 7.7/device2025-09: 3 reports for this device; peer average 7/device2025-10: 1 reports for this device; peer average 7.05/device2025-11: 0 reports for this device; peer average 16.97/device2025-12: 1 reports for this device; peer average 8.75/device2026-01: 1 reports for this device; peer average 8.62/device2026-02: 4 reports for this device; peer average 18.97/device2026-03: 0 reports for this device; peer average 8.78/device2026-04: 0 reports for this device; peer average 11.63/device2026-05: 0 reports for this device; peer average 11.57/device2026-06: 0 reports for this device; peer average 14.08/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0106.09
2019-0205.59
2019-0306.19
2019-0407.81
2019-0506.19
2019-0604
2019-0706.26
2019-0807.14
2019-0908.45
2019-1006.87
2019-1108.74
2019-1207.84
2020-0117.88
2020-0205.09
2020-03011.85
2020-04010.61
2020-0508.36
2020-0606.16
2020-0707.48
2020-0808.52
2020-0907.38
2020-10010
2020-11111.68
2020-12311.65
2021-01015.59
2021-02013.16
2021-0309.9
2021-04011.75
2021-0509.33
2021-0607.84
2021-07012.05
2021-0809.17
2021-0909.29
2021-10011.68
2021-1139.78
2021-12010
2022-0107.76
2022-02011.54
2022-03010.67
2022-0406.19
2022-0508.31
2022-0617.57
2022-0726.16
2022-0808.39
2022-0936.64
2022-1008.06
2022-11411.06
2022-1228.96
2023-01311.86
2023-02112.58
2023-03114.73
2023-04114.78
2023-05013.18
2023-06016.77
2023-07317.81
2023-08120.46
2023-09013.43
2023-10116.51
2023-1129.24
2023-12015.57
2024-01010.25
2024-02016.66
2024-03240.35
2024-04061.7
2024-05072.31
2024-06069.97
2024-07055.17
2024-08032.98
2024-09128.96
2024-10117.14
2024-11015.37
2024-12010.96
2025-0108.77
2025-0207.59
2025-0307.76
2025-04010.04
2025-05012.83
2025-06013.22
2025-0707.86
2025-0807.7
2025-0937
2025-1017.05
2025-11016.97
2025-1218.75
2026-0118.62
2026-02418.97
2026-0308.78
2026-04011.63
2026-05011.57
2026-06014.08
This device (reports/month)Average device in GAT (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
2026-02-240002936485-2026-00118MalfunctionAvailableexact di
2026-02-240002936485-2026-00121MalfunctionAvailableexact di
2026-02-240002936485-2026-00119MalfunctionAvailableexact di
2026-02-240002936485-2026-00120MalfunctionAvailableexact di
2026-01-150002936485-2026-00027MalfunctionAvailableexact di
2025-12-100002936485-2025-00976MalfunctionAvailableexact di
2025-10-200002936485-2025-00854MalfunctionAvailableexact di
2025-09-110002936485-2025-00778MalfunctionAvailableexact di
2025-09-100002936485-2025-00773MalfunctionAvailableexact di
2025-09-020002936485-2025-00755MalfunctionAvailableexact di
2024-10-240002936485-2024-00724MalfunctionAvailableexact di
2024-09-060002936485-2024-00633InjuryAvailableexact di
2024-03-130002936485-2024-00220MalfunctionAvailableexact di
2024-03-110002936485-2024-00209InjuryAvailableexact di
2023-11-290002936485-2023-01209MalfunctionAvailableexact di
Showing 1–15 of 47
Regulatory clearances
  • 510(k)K153087Substantially equivalent (SESE) · 2016-07-14clearance family

Predicate lineage

Cited as predicate by: K262369

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2026-06-18NAINo action indicatedInternational Life Sciences0
2026-02-20VAIVoluntary action indicatedStryker Puerto Rico, LLC2
2025-12-11NAINo action indicatedStryker Manufacturing Kalamazoo0
2025-05-22NAINo action indicatedStryker Macroom0
2025-03-27VAIVoluntary action indicatedStryker GmbH1
2025-03-27VAIVoluntary action indicatedStryker GmbH1
2025-02-27NAINo action indicatedStryker Leibinger GmbH & Co. KG0
2025-01-30NAINo action indicatedSerf0
2024-12-18VAIVoluntary action indicatedStryker Neurovascular1
2024-11-15VAIVoluntary action indicatedStryker Medical Division of Stryker Corporation2
2024-11-13NAINo action indicatedPOM Medical LLC0
2024-07-25VAIVoluntary action indicatedStryker Ireland, Ltd., Instruments Division1
2024-05-03NAINo action indicatedStryker Neurovascular, Inc.0
2024-04-18NAINo action indicatedPhysio-Control, Inc.0
2023-12-01VAIVoluntary action indicatedHowmedica Osteonics Corp.1
2023-05-15VAIVoluntary action indicatedLimFlow, Inc.2
2023-04-25NAINo action indicatedStryker Puerto Rico, LLC0
2023-01-24VAIVoluntary action indicatedStryker Corporation2
2023-01-24VAIVoluntary action indicatedStryker Corporation2
2022-03-08VAIVoluntary action indicatedPOM Medical LLC0
2017-04-06WLWarning LetterEntellus Medical Inc.—
2015-04-08WLWarning LetterThermedx LLC—
2013-11-26INJInjunctionPhysio-Control, Inc.—
2013-03-06WLWarning LetterStryker Corporation—
2013-03-06WLWarning LetterStryker Corporation—
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