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.
190 linked reportsInjury 109Malfunction 81
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 1 | 1 |
| 2019-02 | 0 | 15.5 |
| 2019-03 | 7 | 29 |
| 2019-04 | 3 | 15 |
| 2019-05 | 6 | 11.67 |
| 2019-06 | 2 | 14.33 |
| 2019-07 | 7 | 10.33 |
| 2019-08 | 1 | 15.67 |
| 2019-09 | 2 | 8.2 |
| 2019-10 | 5 | 15.33 |
| 2019-11 | 3 | 14.67 |
| 2019-12 | 1 | 13.25 |
| 2020-01 | 0 | 22 |
| 2020-02 | 0 | 20 |
| 2020-03 | 0 | 20.5 |
| 2020-04 | 0 | 34 |
| 2020-05 | 4 | 6 |
| 2020-06 | 3 | 6.7 |
| 2020-07 | 1 | 7.57 |
| 2020-08 | 1 | 8.33 |
| 2020-09 | 8 | 10.4 |
| 2020-10 | 3 | 6.55 |
| 2020-11 | 4 | 10.33 |
| 2020-12 | 9 | 8.71 |
| 2021-01 | 3 | 6.67 |
| 2021-02 | 1 | 5.71 |
| 2021-03 | 2 | 7.4 |
| 2021-04 | 0 | 9.17 |
| 2021-05 | 5 | 7.67 |
| 2021-06 | 4 | 6.78 |
| 2021-07 | 0 | 6.2 |
| 2021-08 | 5 | 10.4 |
| 2021-09 | 2 | 11.8 |
| 2021-10 | 8 | 9.75 |
| 2021-11 | 4 | 5.5 |
| 2021-12 | 7 | 8.25 |
| 2022-01 | 1 | 15.5 |
| 2022-02 | 5 | 4.36 |
| 2022-03 | 5 | 8.14 |
| 2022-04 | 0 | 7.4 |
| 2022-05 | 0 | 6 |
| 2022-06 | 0 | 10.17 |
| 2022-07 | 3 | 14 |
| 2022-08 | 0 | 6.63 |
| 2022-09 | 0 | 14 |
| 2022-10 | 8 | 9.33 |
| 2022-11 | 2 | 8.17 |
| 2022-12 | 2 | 11.75 |
| 2023-01 | 1 | 10 |
| 2023-02 | 1 | 8.2 |
| 2023-03 | 0 | 8.25 |
| 2023-04 | 2 | 9 |
| 2023-05 | 3 | 10.75 |
| 2023-06 | 1 | 11.2 |
| 2023-07 | 0 | 9.67 |
| 2023-08 | 0 | 6.67 |
| 2023-09 | 1 | 6.4 |
| 2023-10 | 1 | 7.25 |
| 2023-11 | 0 | 14 |
| 2023-12 | 0 | 6.25 |
| 2024-01 | 0 | 14.75 |
| 2024-02 | 1 | 5.6 |
| 2024-03 | 0 | 7.75 |
| 2024-04 | 0 | 5.2 |
| 2024-05 | 2 | 3.6 |
| 2024-06 | 2 | 7 |
| 2024-07 | 1 | 5.17 |
| 2024-08 | 0 | 5 |
| 2024-09 | 0 | 8 |
| 2024-10 | 4 | 7.33 |
| 2024-11 | 1 | 3.8 |
| 2024-12 | 0 | 4.83 |
| 2025-01 | 1 | 5.4 |
| 2025-02 | 1 | 3 |
| 2025-03 | 3 | 4.2 |
| 2025-04 | 0 | 3.83 |
| 2025-05 | 1 | 2.6 |
| 2025-06 | 0 | 4.33 |
| 2025-07 | 1 | 6.25 |
| 2025-08 | 0 | 5.33 |
| 2025-09 | 1 | 3 |
| 2025-10 | 2 | 3.2 |
| 2025-11 | 0 | 3.43 |
| 2025-12 | 4 | 3 |
| 2026-01 | 1 | 3 |
| 2026-02 | 1 | 2.75 |
| 2026-03 | 4 | 2.6 |
| 2026-04 | 8 | 6 |
| 2026-05 | 2 | 3.33 |
| 2026-06 | 1 | 3 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2020-10-16 | Z-0431-2021 | Class II | Terminated | Potential for the inner bit to contain a crack, that may or may not be visible, which may lead to metal fragments entering the surgical site and/or delayed disengagment during use.Distribution: Nationwide Foreign: Australia Brazil Canada Chile Colombia Hong Kong Italy Mexico Netherlands Netherlands New Zealand South Africa South Korea Spain Sweden Switzerland United Kingdom | 18,492 devices. Expanded Recall total: 18,594 devices | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-03 | 3015967359-2026-00421 | Injury | Available | exact di |
| 2026-05-20 | 3015967359-2026-00359 | Injury | Available | exact di |
| 2026-05-20 | 3015967359-2026-00357 | Injury | Available | exact di |
| 2026-04-29 | 3015967359-2026-00270 | Injury | Available | exact di |
| 2026-04-29 | 3015967359-2026-00278 | Injury | Available | exact di |
| 2026-04-28 | 3015967359-2026-00260 | Injury | Available | exact di |
| 2026-04-28 | 3015967359-2026-00262 | Injury | Available | exact di |
| 2026-04-24 | 3015967359-2026-00256 | Injury | Available | exact di |
| 2026-04-23 | 3015967359-2026-00251 | Injury | Available | exact di |
| 2026-04-13 | 3015967359-2026-00220 | Injury | Available | exact di |
| 2026-04-13 | 3015967359-2026-00219 | Injury | Available | exact di |
| 2026-03-30 | 24710778 | Injury | Available | catalog number |
| 2026-02-10 | 3015967359-2026-00090 | Injury | Available | exact di |
| 2026-01-23 | 3015967359-2026-99140 | Malfunction | Available | exact di |
| 2025-12-18 | 3015967359-2025-01742 | Injury | Available | exact di |
Showing the most recent 187 of 190 linked reports.
Showing 1–15 of 187
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2026-06-18 | NAI | No action indicated | International Life Sciences | 0 |
| 2026-02-20 | VAI | Voluntary action indicated | Stryker Puerto Rico, LLC | 2 |
| 2025-12-11 | NAI | No action indicated | Stryker Manufacturing Kalamazoo | 0 |
| 2025-05-22 | NAI | No action indicated | Stryker Macroom | 0 |
| 2025-03-27 | VAI | Voluntary action indicated | Stryker GmbH | 1 |
| 2025-03-27 | VAI | Voluntary action indicated | Stryker GmbH | 1 |
| 2025-02-27 | NAI | No action indicated | Stryker Leibinger GmbH & Co. KG | 0 |
| 2025-01-30 | NAI | No action indicated | Serf | 0 |
| 2024-12-18 | VAI | Voluntary action indicated | Stryker Neurovascular | 1 |
| 2024-11-15 | VAI | Voluntary action indicated | Stryker Medical Division of Stryker Corporation | 2 |
| 2024-11-13 | NAI | No action indicated | POM Medical LLC | 0 |
| 2024-07-25 | VAI | Voluntary action indicated | Stryker Ireland, Ltd., Instruments Division | 1 |
| 2024-05-03 | NAI | No action indicated | Stryker Neurovascular, Inc. | 0 |
| 2024-04-18 | NAI | No action indicated | Physio-Control, Inc. | 0 |
| 2023-12-01 | VAI | Voluntary action indicated | Howmedica Osteonics Corp. | 1 |
| 2023-05-15 | VAI | Voluntary action indicated | LimFlow, Inc. | 2 |
| 2023-04-25 | NAI | No action indicated | Stryker Puerto Rico, LLC | 0 |
| 2023-01-24 | VAI | Voluntary action indicated | Stryker Corporation | 2 |
| 2023-01-24 | VAI | Voluntary action indicated | Stryker Corporation | 2 |
| 2022-03-08 | VAI | Voluntary action indicated | POM Medical LLC | 0 |
| 2017-04-06 | WL | Warning Letter | Entellus Medical Inc. | — |
| 2015-04-08 | WL | Warning Letter | Thermedx LLC | — |
| 2013-11-26 | INJ | Injunction | Physio-Control, Inc. | — |
| 2013-03-06 | WL | Warning Letter | Stryker Corporation | — |
| 2013-03-06 | WL | Warning Letter | Stryker Corporation | — |
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