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.
300 linked reportsMalfunction 232Injury 68
| 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 | 0 | 7.49 |
| 2019-09 | 0 | 7.85 |
| 2019-10 | 1 | 7.27 |
| 2019-11 | 0 | 9.91 |
| 2019-12 | 2 | 10.08 |
| 2020-01 | 2 | 8.04 |
| 2020-02 | 19 | 9.15 |
| 2020-03 | 23 | 9.62 |
| 2020-04 | 10 | 9.53 |
| 2020-05 | 3 | 11.43 |
| 2020-06 | 13 | 8.71 |
| 2020-07 | 16 | 9.7 |
| 2020-08 | 5 | 8.58 |
| 2020-09 | 15 | 8.91 |
| 2020-10 | 25 | 9.9 |
| 2020-11 | 23 | 10.94 |
| 2020-12 | 9 | 9.27 |
| 2021-01 | 21 | 9.05 |
| 2021-02 | 20 | 9.77 |
| 2021-03 | 16 | 9.35 |
| 2021-04 | 13 | 8.9 |
| 2021-05 | 16 | 9.8 |
| 2021-06 | 13 | 11.37 |
| 2021-07 | 8 | 8.74 |
| 2021-08 | 2 | 10.53 |
| 2021-09 | 0 | 13 |
| 2021-10 | 0 | 8.34 |
| 2021-11 | 0 | 11.01 |
| 2021-12 | 1 | 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 | 1 | 9.36 |
| 2022-07 | 1 | 8.79 |
| 2022-08 | 1 | 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 | 6 | 10.04 |
| 2023-04 | 1 | 10.25 |
| 2023-05 | 1 | 10.82 |
| 2023-06 | 0 | 12.34 |
| 2023-07 | 0 | 14.14 |
| 2023-08 | 2 | 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 | 1 | 12.95 |
| 2024-06 | 0 | 12.52 |
| 2024-07 | 1 | 13.91 |
| 2024-08 | 0 | 18.98 |
| 2024-09 | 1 | 14.7 |
| 2024-10 | 1 | 18.36 |
| 2024-11 | 0 | 10.72 |
| 2024-12 | 1 | 10.63 |
| 2025-01 | 2 | 12.32 |
| 2025-02 | 0 | 13.73 |
| 2025-03 | 0 | 12.56 |
| 2025-04 | 1 | 13.77 |
| 2025-05 | 0 | 13.22 |
| 2025-06 | 0 | 16.69 |
| 2025-07 | 0 | 12.44 |
| 2025-08 | 0 | 10.63 |
| 2025-09 | 1 | 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 | 2 | 8.88 |
| 2026-04 | 0 | 7.34 |
| 2026-05 | 0 | 7.59 |
| 2026-06 | 0 | 5.85 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2021-09-22 | Z-0118-2022 | Class I | Open, Classified | The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which led to the inaccurate placement of an electrode during surgery. The firm has received 3 global complaints related to the issue. An incorrect trajectory could result in serious injury or death if undetected during surgery.Distribution: US Nationwide distribution and International Distribution to countries of: Australia, Taiwan, China, Thailand, Japan, India, South Korea, and the Netherlands. | 119 (US); 55 (OUS) | clearance family |
| 2020-01-06 | Z-1150-2020 | Class II | Terminated | Some cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displayed properly in two and three dimension views when using ROSA Brain software, potentially compromising the surgery planning.Distribution: US Nationwide | 47 units | clearance family |
| 2020-01-06 | Z-1151-2020 | Class II | Terminated | Some cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displayed properly in two and three dimension views when using ROSA Brain software, potentially compromising the surgery planning.Distribution: US Nationwide | 39 units | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-03-18 | 3009185973-2026-00004 | Malfunction | Available | exact di |
| 2026-03-13 | 3009185973-2026-00003 | Malfunction | Available | exact di |
| 2025-09-17 | 3009185973-2025-00011 | Injury | Available | exact di |
| 2025-04-15 | 3009185973-2025-00005 | Injury | Available | exact di |
| 2025-01-23 | 3009185973-2025-00002 | Injury | Available | exact di |
| 2025-01-07 | 3009185973-2025-00001 | Malfunction | Available | exact di |
| 2024-12-31 | 3009185973-2024-00022 | Malfunction | Available | exact di |
| 2024-10-25 | 3009185973-2024-00015 | Injury | Available | exact di |
| 2024-09-30 | 3009185973-2024-00013 | Injury | Available | exact di |
| 2024-07-09 | 3009185973-2024-00006 | Injury | Available | exact di |
| 2024-05-23 | 3009185973-2024-00004 | Malfunction | Available | exact di |
| 2023-08-09 | 3009185973-2023-00020 | Malfunction | Available | exact di |
| 2023-08-02 | 3009185973-2023-00019 | Malfunction | Available | exact di |
| 2023-05-16 | 3009185973-2023-00014 | Malfunction | Available | exact di |
| 2023-04-17 | 3009185973-2023-00012 | Malfunction | Available | exact di |
Showing the most recent 200 of 300 linked reports.
Showing 1–15 of 200
Regulatory clearances
- 510(k)K182848Substantially equivalent (SESE) · 2019-03-22clearance family
- 510(k)K182417Substantially equivalent (SESE) · 2019-02-07clearance family
Predicate lineage
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 |
|---|---|---|---|---|
| 2022-06-30 | VAI | Voluntary action indicated | Medtech LLC | 1 |
| 2022-06-30 | VAI | Voluntary action indicated | Medtech LLC | 1 |
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