Regulatory presence across jurisdictions
The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.
- United StatesCranial Navigation04056481143848
- United StatesCranial Navigation System Navigation04056481141356
- United StatesNavigation Software Cranial04056481140663
- United StatesRegistration Software Cranial04056481140687
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.
39 linked reportsInjury 39
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-10 | 2 | — |
| 2021-05 | 1 | — |
| 2021-06 | 2 | — |
| 2021-07 | 1 | — |
| 2021-10 | 1 | — |
| 2021-11 | 1 | — |
| 2022-06 | 1 | — |
| 2022-09 | 1 | — |
| 2023-02 | 1 | — |
| 2023-05 | 3 | — |
| 2023-10 | 3 | — |
| 2023-11 | 2 | — |
| 2024-03 | 1 | — |
| 2024-04 | 1 | — |
| 2024-05 | 1 | — |
| 2024-07 | 1 | — |
| 2024-09 | 1 | — |
| 2024-10 | 1 | — |
| 2024-11 | 1 | — |
| 2025-01 | 1 | — |
| 2025-02 | 2 | — |
| 2025-03 | 2 | — |
| 2025-09 | 1 | — |
| 2025-10 | 1 | — |
| 2025-11 | 1 | — |
| 2026-02 | 1 | — |
| 2026-04 | 2 | — |
| 2026-06 | 2 | — |
Failure-mode summaryAI-generated
39 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-02 | 8043933-2026-00037 | Injury | Available | exact di |
| 2026-06-01 | 8043933-2026-00035 | Injury | Available | exact di |
| 2026-04-15 | 8043933-2026-00023 | Injury | Available | exact di |
| 2026-04-01 | 8043933-2026-00019 | Injury | Available | exact di |
| 2026-02-18 | 8043933-2026-00008 | Injury | Available | exact di |
| 2025-11-28 | 8043933-2025-00089 | Injury | Available | exact di |
| 2025-10-30 | 8043933-2025-00077 | Injury | Available | exact di |
| 2025-09-04 | 8043933-2025-00063 | Injury | Available | exact di |
| 2025-03-07 | 8043933-2025-00018 | Injury | Available | exact di |
| 2025-03-07 | 8043933-2025-00017 | Injury | Available | exact di |
| 2025-02-28 | 8043933-2025-00015 | Injury | Available | exact di |
| 2025-02-18 | 8043933-2025-00013 | Injury | Available | exact di |
| 2025-01-30 | 8043933-2025-00006 | Injury | Available | exact di |
| 2024-11-20 | 8043933-2024-00073 | Injury | Available | exact di |
| 2024-10-22 | 8043933-2024-00064 | Injury | Available | exact di |
Showing 1–15 of 39
Regulatory clearances
None linked.
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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