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.
349 linked reportsMalfunction 341Injury 7Death 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 1 | 12.92 |
| 2019-02 | 2 | 14.35 |
| 2019-03 | 2 | 14.05 |
| 2019-04 | 0 | 18.63 |
| 2019-05 | 0 | 19.54 |
| 2019-06 | 2 | 20.19 |
| 2019-07 | 1 | 13.37 |
| 2019-08 | 2 | 11.15 |
| 2019-09 | 1 | 11.95 |
| 2019-10 | 1 | 9.58 |
| 2019-11 | 1 | 11.88 |
| 2019-12 | 2 | 14.46 |
| 2020-01 | 5 | 11.27 |
| 2020-02 | 4 | 12.22 |
| 2020-03 | 3 | 12.88 |
| 2020-04 | 0 | 10.44 |
| 2020-05 | 3 | 15.5 |
| 2020-06 | 1 | 12.21 |
| 2020-07 | 2 | 14.34 |
| 2020-08 | 6 | 12.98 |
| 2020-09 | 3 | 12.31 |
| 2020-10 | 2 | 12.61 |
| 2020-11 | 2 | 14.12 |
| 2020-12 | 7 | 12.64 |
| 2021-01 | 2 | 11.89 |
| 2021-02 | 1 | 14.14 |
| 2021-03 | 4 | 13.25 |
| 2021-04 | 5 | 13.21 |
| 2021-05 | 1 | 14.8 |
| 2021-06 | 1 | 18.26 |
| 2021-07 | 2 | 13.79 |
| 2021-08 | 1 | 17.29 |
| 2021-09 | 0 | 24.68 |
| 2021-10 | 1 | 14.32 |
| 2021-11 | 1 | 16.72 |
| 2021-12 | 1 | 12.67 |
| 2022-01 | 2 | 10.59 |
| 2022-02 | 3 | 13.53 |
| 2022-03 | 1 | 15.09 |
| 2022-04 | 3 | 12.75 |
| 2022-05 | 2 | 16.55 |
| 2022-06 | 2 | 15.68 |
| 2022-07 | 4 | 12.74 |
| 2022-08 | 5 | 13.73 |
| 2022-09 | 4 | 15.67 |
| 2022-10 | 2 | 18.18 |
| 2022-11 | 5 | 16.94 |
| 2022-12 | 4 | 16.56 |
| 2023-01 | 1 | 14 |
| 2023-02 | 3 | 12.62 |
| 2023-03 | 8 | 16.68 |
| 2023-04 | 4 | 14.38 |
| 2023-05 | 5 | 16.67 |
| 2023-06 | 3 | 24.22 |
| 2023-07 | 3 | 25.39 |
| 2023-08 | 5 | 21.23 |
| 2023-09 | 3 | 17.03 |
| 2023-10 | 7 | 17.29 |
| 2023-11 | 7 | 18.43 |
| 2023-12 | 5 | 20.54 |
| 2024-01 | 11 | 25.65 |
| 2024-02 | 2 | 20.49 |
| 2024-03 | 2 | 21.69 |
| 2024-04 | 5 | 22.32 |
| 2024-05 | 4 | 18.44 |
| 2024-06 | 3 | 19.81 |
| 2024-07 | 12 | 23.6 |
| 2024-08 | 9 | 29.73 |
| 2024-09 | 8 | 22.75 |
| 2024-10 | 8 | 27.4 |
| 2024-11 | 7 | 14.37 |
| 2024-12 | 2 | 16.74 |
| 2025-01 | 7 | 16.27 |
| 2025-02 | 12 | 21.38 |
| 2025-03 | 12 | 25.24 |
| 2025-04 | 11 | 23.34 |
| 2025-05 | 17 | 20.44 |
| 2025-06 | 12 | 33.41 |
| 2025-07 | 5 | 20.35 |
| 2025-08 | 10 | 17.63 |
| 2025-09 | 6 | 19.99 |
| 2025-10 | 4 | 18.6 |
| 2025-11 | 3 | 16.83 |
| 2025-12 | 5 | 15.93 |
| 2026-01 | 1 | 17 |
| 2026-02 | 1 | 14.12 |
| 2026-03 | 0 | 15.06 |
| 2026-04 | 3 | 11.52 |
| 2026-05 | 2 | 11.51 |
| 2026-06 | 1 | 8.95 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-29 | 1723170-2026-00935 | Malfunction | — | model number |
| 2026-05-27 | 1723170-2026-00806 | Malfunction | Available | model number |
| 2026-05-06 | 1723170-2026-00708 | Malfunction | Available | model number |
| 2026-04-09 | 1723170-2026-00574 | Malfunction | Available | model number |
| 2026-04-09 | 1723170-2026-00572 | Malfunction | Available | model number |
| 2026-04-09 | 1723170-2026-00573 | Malfunction | Available | model number |
| 2026-02-20 | 1723170-2026-00280 | Malfunction | Available | model number |
| 2026-01-23 | 1723170-2026-00137 | Malfunction | Available | model number |
| 2025-12-24 | 1723170-2025-03977 | Malfunction | Available | model number |
| 2025-12-15 | 1723170-2025-03914 | Malfunction | Available | model number |
| 2025-12-12 | 1723170-2025-03904 | Malfunction | Available | model number |
| 2025-12-03 | 1723170-2025-03861 | Malfunction | Available | model number |
| 2025-12-03 | 1723170-2025-03854 | Malfunction | Available | model number |
| 2025-11-13 | 1723170-2025-03722 | Malfunction | Available | model number |
| 2025-11-11 | 1723170-2025-03708 | Malfunction | Available | model number |
Showing the most recent 200 of 349 linked reports.
Showing 1–15 of 200
Regulatory clearances
Predicate lineage
Cited as predicate by: K170018, K182077, K182104, K191597, K200047, K200791, K201175, K211064, K212194, K220241, K221344, K230087, K231527, K241130, K241333, K253381
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
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2024-02-09 | VAI | Voluntary action indicated | Medtronic Navigation, Inc. | 3 |
| 2021-06-29 | VAI | Voluntary action indicated | Medtronic Navigation, Inc. | 3 |
| 2019-09-30 | VAI | Voluntary action indicated | Medtronic Navigation, Inc. | 1 |
| 2016-08-18 | VAI | Voluntary action indicated | Medtronic Navigation, Inc. | 0 |
| 2014-12-15 | NAI | No action indicated | Medtronic Navigation, Inc. | 0 |
| 2014-02-19 | VAI | Voluntary action indicated | Medtronic Navigation, Inc. | 5 |
| 2012-09-06 | NAI | No action indicated | Medtronic Navigation, Inc. | 0 |
| 2012-05-01 | NAI | No action indicated | Medtronic Navigation, Inc. | 0 |
| 2011-03-24 | VAI | Voluntary action indicated | Medtronic Navigation, Inc. | 1 |
| 2010-05-07 | WL | Warning Letter | Medtronic Navigation, Inc. | — |
| 2010-02-04 | OAI | Official action indicated | Medtronic Navigation, Inc. | 9 |
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