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.
4 linked reportsInjury 4
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 9.11 |
| 2019-02 | 0 | 9.71 |
| 2019-03 | 0 | 9.79 |
| 2019-04 | 0 | 11.87 |
| 2019-05 | 0 | 13.04 |
| 2019-06 | 0 | 13.02 |
| 2019-07 | 0 | 9.88 |
| 2019-08 | 1 | 7.49 |
| 2019-09 | 0 | 7.85 |
| 2019-10 | 0 | 7.27 |
| 2019-11 | 0 | 9.91 |
| 2019-12 | 0 | 10.08 |
| 2020-01 | 0 | 8.04 |
| 2020-02 | 1 | 9.15 |
| 2020-03 | 0 | 9.62 |
| 2020-04 | 0 | 9.53 |
| 2020-05 | 0 | 11.43 |
| 2020-06 | 0 | 8.71 |
| 2020-07 | 0 | 9.7 |
| 2020-08 | 0 | 8.58 |
| 2020-09 | 0 | 8.91 |
| 2020-10 | 0 | 9.9 |
| 2020-11 | 0 | 10.94 |
| 2020-12 | 0 | 9.27 |
| 2021-01 | 0 | 9.05 |
| 2021-02 | 0 | 9.77 |
| 2021-03 | 0 | 9.35 |
| 2021-04 | 0 | 8.9 |
| 2021-05 | 0 | 9.8 |
| 2021-06 | 0 | 11.37 |
| 2021-07 | 0 | 8.74 |
| 2021-08 | 0 | 10.53 |
| 2021-09 | 1 | 13 |
| 2021-10 | 0 | 8.34 |
| 2021-11 | 0 | 11.01 |
| 2021-12 | 0 | 7.44 |
| 2022-01 | 0 | 6.82 |
| 2022-02 | 0 | 7.95 |
| 2022-03 | 0 | 9.35 |
| 2022-04 | 0 | 6.39 |
| 2022-05 | 0 | 8.87 |
| 2022-06 | 0 | 9.36 |
| 2022-07 | 0 | 8.79 |
| 2022-08 | 0 | 8.72 |
| 2022-09 | 0 | 8.74 |
| 2022-10 | 0 | 11.56 |
| 2022-11 | 0 | 10.32 |
| 2022-12 | 0 | 10.44 |
| 2023-01 | 0 | 9.14 |
| 2023-02 | 0 | 8.45 |
| 2023-03 | 0 | 10.04 |
| 2023-04 | 0 | 10.25 |
| 2023-05 | 1 | 10.82 |
| 2023-06 | 0 | 12.34 |
| 2023-07 | 0 | 14.14 |
| 2023-08 | 0 | 13.16 |
| 2023-09 | 0 | 11.4 |
| 2023-10 | 0 | 10.8 |
| 2023-11 | 0 | 14.61 |
| 2023-12 | 0 | 12.27 |
| 2024-01 | 0 | 16.51 |
| 2024-02 | 0 | 12.43 |
| 2024-03 | 0 | 14.98 |
| 2024-04 | 0 | 13.44 |
| 2024-05 | 0 | 12.95 |
| 2024-06 | 0 | 12.52 |
| 2024-07 | 0 | 13.91 |
| 2024-08 | 0 | 18.98 |
| 2024-09 | 0 | 14.7 |
| 2024-10 | 0 | 18.36 |
| 2024-11 | 0 | 10.72 |
| 2024-12 | 0 | 10.63 |
| 2025-01 | 0 | 12.32 |
| 2025-02 | 0 | 13.73 |
| 2025-03 | 0 | 12.56 |
| 2025-04 | 0 | 13.77 |
| 2025-05 | 0 | 13.22 |
| 2025-06 | 0 | 16.69 |
| 2025-07 | 0 | 12.44 |
| 2025-08 | 0 | 10.63 |
| 2025-09 | 0 | 11.02 |
| 2025-10 | 0 | 10.7 |
| 2025-11 | 0 | 9.45 |
| 2025-12 | 0 | 8.85 |
| 2026-01 | 0 | 10.24 |
| 2026-02 | 0 | 8.24 |
| 2026-03 | 0 | 8.88 |
| 2026-04 | 0 | 7.34 |
| 2026-05 | 0 | 7.59 |
| 2026-06 | 0 | 5.85 |
Failure-mode summaryAI-generated
4 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2019-02-27 | Z-1082-2019 | Class I | Terminated | In certain occurrences, the affected navigation software application might unexpectedly display a navigated instrument in an axial, coronal/sagittal (ACS) view representation with fixed planes in the image reconstruction (the not-updated ACS view ), instead of displaying the desirable view representation Inline View , which is commonly used for navigating invasive instruments at the spine. This could lead the surgeon to be unable to determine the position of the navigated instrument. This might occur after a crash restore or after changing between different navigation workflows during the same patient treatment.Distribution: Worldwide Distribution: US (Nationwide) and countries of: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Ecuador, France, Germany, Greece, Hong Kong, Ireland, Italy, Japan, Kazakhstan, Malaysia, New Zealand, Philippines, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand and United Kingdom. | 148 units | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2023-05-17 | 8043933-2023-00039 | Injury | Available | exact di |
| 2021-09-23 | 8043933-2021-00060 | Injury | Available | exact di |
| 2020-02-06 | 8043933-2020-00009 | Injury | Available | exact di |
| 2019-08-21 | 8043933-2019-00037 | Injury | Available | exact di |
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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