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.
125 linked reportsInjury 125
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.67 |
| 2019-02 | 0 | 3.61 |
| 2019-03 | 0 | 3.19 |
| 2019-04 | 0 | 2.75 |
| 2019-05 | 0 | 3.1 |
| 2019-06 | 0 | 2.72 |
| 2019-07 | 0 | 3.23 |
| 2019-08 | 0 | 2.93 |
| 2019-09 | 0 | 2.89 |
| 2019-10 | 0 | 3.84 |
| 2019-11 | 0 | 5.54 |
| 2019-12 | 0 | 3.54 |
| 2020-01 | 0 | 3.39 |
| 2020-02 | 0 | 4.56 |
| 2020-03 | 0 | 4.41 |
| 2020-04 | 0 | 7.69 |
| 2020-05 | 1 | 2.37 |
| 2020-06 | 0 | 3.54 |
| 2020-07 | 2 | 3.94 |
| 2020-08 | 1 | 2.61 |
| 2020-09 | 0 | 3.93 |
| 2020-10 | 0 | 5.63 |
| 2020-11 | 0 | 5.77 |
| 2020-12 | 1 | 4.33 |
| 2021-01 | 1 | 4.68 |
| 2021-02 | 2 | 4.08 |
| 2021-03 | 3 | 3.82 |
| 2021-04 | 8 | 3.82 |
| 2021-05 | 2 | 4.15 |
| 2021-06 | 3 | 3.79 |
| 2021-07 | 2 | 3.25 |
| 2021-08 | 3 | 2.96 |
| 2021-09 | 3 | 2.92 |
| 2021-10 | 7 | 2.27 |
| 2021-11 | 2 | 4.24 |
| 2021-12 | 2 | 2.72 |
| 2022-01 | 2 | 2.54 |
| 2022-02 | 4 | 3.16 |
| 2022-03 | 3 | 3.32 |
| 2022-04 | 2 | 2.45 |
| 2022-05 | 6 | 3.91 |
| 2022-06 | 6 | 4.21 |
| 2022-07 | 5 | 3.33 |
| 2022-08 | 5 | 2.9 |
| 2022-09 | 2 | 2.32 |
| 2022-10 | 5 | 3.76 |
| 2022-11 | 1 | 3.44 |
| 2022-12 | 4 | 4.22 |
| 2023-01 | 5 | 3.18 |
| 2023-02 | 4 | 3.44 |
| 2023-03 | 2 | 3.77 |
| 2023-04 | 0 | 3.26 |
| 2023-05 | 2 | 3.02 |
| 2023-06 | 1 | 2.6 |
| 2023-07 | 1 | 2.69 |
| 2023-08 | 1 | 2.51 |
| 2023-09 | 1 | 4.04 |
| 2023-10 | 4 | 3.21 |
| 2023-11 | 2 | 9.13 |
| 2023-12 | 0 | 4 |
| 2024-01 | 1 | 3.71 |
| 2024-02 | 3 | 4.15 |
| 2024-03 | 1 | 4.4 |
| 2024-04 | 1 | 3.95 |
| 2024-05 | 0 | 4.89 |
| 2024-06 | 0 | 4.54 |
| 2024-07 | 1 | 3.92 |
| 2024-08 | 0 | 4.59 |
| 2024-09 | 1 | 4.53 |
| 2024-10 | 0 | 6.31 |
| 2024-11 | 1 | 4.74 |
| 2024-12 | 2 | 4.01 |
| 2025-01 | 0 | 8.37 |
| 2025-02 | 0 | 4.23 |
| 2025-03 | 0 | 3.59 |
| 2025-04 | 0 | 4.2 |
| 2025-05 | 2 | 4.57 |
| 2025-06 | 0 | 4.14 |
| 2025-07 | 0 | 4.32 |
| 2025-08 | 0 | 5.03 |
| 2025-09 | 0 | 3.85 |
| 2025-10 | 1 | 3.97 |
| 2025-11 | 0 | 4.12 |
| 2025-12 | 0 | 4.59 |
| 2026-01 | 0 | 4.53 |
| 2026-02 | 0 | 4.25 |
| 2026-03 | 0 | 4.08 |
| 2026-04 | 0 | 3.9 |
| 2026-05 | 0 | 4.99 |
| 2026-06 | 0 | 3.99 |
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 |
|---|---|---|---|---|
| 2025-10-15 | 8043933-2025-00074 | Injury | Available | exact di |
| 2025-05-27 | 8043933-2025-00042 | Injury | Available | exact di |
| 2025-05-14 | 8043933-2025-00038 | Injury | Available | exact di |
| 2024-12-18 | 8043933-2024-00087 | Injury | Available | exact di |
| 2024-12-13 | 8043933-2024-00084 | Injury | Available | exact di |
| 2024-11-06 | 8043933-2024-00068 | Injury | Available | exact di |
| 2024-09-18 | 8043933-2024-00055 | Injury | Available | exact di |
| 2024-07-11 | 8043933-2024-00036 | Injury | Available | exact di |
| 2024-04-30 | 8043933-2024-00028 | Injury | Available | exact di |
| 2024-03-28 | 8043933-2024-00019 | Injury | Available | exact di |
| 2024-02-29 | 8043933-2024-00013 | Injury | Available | exact di |
| 2024-02-29 | 8043933-2024-00012 | Injury | Available | exact di |
| 2024-02-15 | 8043933-2024-00010 | Injury | Available | exact di |
| 2024-01-12 | 8043933-2024-00002 | Injury | Available | exact di |
| 2023-11-10 | 8043933-2023-00075 | Injury | Available | exact di |
Showing 1–15 of 125
Regulatory clearances
Predicate lineage
- K183605
Cited as predicate by: K193307, K201661, K202320, K203679, K212245, K220554, K242271, K252755
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 |
|---|---|---|---|---|
| 2025-02-20 | NAI | No action indicated | Brainlab SE | 0 |
| 2025-02-20 | NAI | No action indicated | Brainlab SE | 0 |
| 2016-02-25 | NAI | No action indicated | Brainlab SE | 0 |
| 2016-02-25 | NAI | No action indicated | Brainlab SE | 0 |
| 2013-06-21 | VAI | Voluntary action indicated | Brainlab SE | 3 |
| 2013-06-21 | VAI | Voluntary action indicated | Brainlab SE | 3 |
| 2011-05-27 | NAI | No action indicated | Brainlab SE | 0 |
| 2011-05-27 | NAI | No action indicated | Brainlab SE | 0 |
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