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.
15 linked reportsMalfunction 14Injury 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 12.92 |
| 2019-02 | 0 | 14.35 |
| 2019-03 | 1 | 14.05 |
| 2019-04 | 1 | 18.63 |
| 2019-05 | 0 | 19.54 |
| 2019-06 | 0 | 20.19 |
| 2019-07 | 1 | 13.37 |
| 2019-08 | 0 | 11.15 |
| 2019-09 | 1 | 11.95 |
| 2019-10 | 1 | 9.58 |
| 2019-11 | 0 | 11.88 |
| 2019-12 | 1 | 14.46 |
| 2020-01 | 0 | 11.27 |
| 2020-02 | 3 | 12.22 |
| 2020-03 | 0 | 12.88 |
| 2020-04 | 0 | 10.44 |
| 2020-05 | 0 | 15.5 |
| 2020-06 | 0 | 12.21 |
| 2020-07 | 1 | 14.34 |
| 2020-08 | 1 | 12.98 |
| 2020-09 | 0 | 12.31 |
| 2020-10 | 1 | 12.61 |
| 2020-11 | 0 | 14.12 |
| 2020-12 | 1 | 12.64 |
| 2021-01 | 1 | 11.89 |
| 2021-02 | 1 | 14.14 |
| 2021-03 | 0 | 13.25 |
| 2021-04 | 0 | 13.21 |
| 2021-05 | 0 | 14.8 |
| 2021-06 | 0 | 18.26 |
| 2021-07 | 0 | 13.79 |
| 2021-08 | 0 | 17.29 |
| 2021-09 | 0 | 24.68 |
| 2021-10 | 0 | 14.32 |
| 2021-11 | 0 | 16.72 |
| 2021-12 | 0 | 12.67 |
| 2022-01 | 0 | 10.59 |
| 2022-02 | 0 | 13.53 |
| 2022-03 | 0 | 15.09 |
| 2022-04 | 0 | 12.75 |
| 2022-05 | 0 | 16.55 |
| 2022-06 | 0 | 15.68 |
| 2022-07 | 0 | 12.74 |
| 2022-08 | 0 | 13.73 |
| 2022-09 | 0 | 15.67 |
| 2022-10 | 0 | 18.18 |
| 2022-11 | 0 | 16.94 |
| 2022-12 | 0 | 16.56 |
| 2023-01 | 0 | 14 |
| 2023-02 | 0 | 12.62 |
| 2023-03 | 0 | 16.68 |
| 2023-04 | 0 | 14.38 |
| 2023-05 | 0 | 16.67 |
| 2023-06 | 0 | 24.22 |
| 2023-07 | 0 | 25.39 |
| 2023-08 | 0 | 21.23 |
| 2023-09 | 0 | 17.03 |
| 2023-10 | 0 | 17.29 |
| 2023-11 | 0 | 18.43 |
| 2023-12 | 0 | 20.54 |
| 2024-01 | 0 | 25.65 |
| 2024-02 | 0 | 20.49 |
| 2024-03 | 0 | 21.69 |
| 2024-04 | 0 | 22.32 |
| 2024-05 | 0 | 18.44 |
| 2024-06 | 0 | 19.81 |
| 2024-07 | 0 | 23.6 |
| 2024-08 | 0 | 29.73 |
| 2024-09 | 0 | 22.75 |
| 2024-10 | 0 | 27.4 |
| 2024-11 | 0 | 14.37 |
| 2024-12 | 0 | 16.74 |
| 2025-01 | 0 | 16.27 |
| 2025-02 | 0 | 21.38 |
| 2025-03 | 0 | 25.24 |
| 2025-04 | 0 | 23.34 |
| 2025-05 | 0 | 20.44 |
| 2025-06 | 0 | 33.41 |
| 2025-07 | 0 | 20.35 |
| 2025-08 | 0 | 17.63 |
| 2025-09 | 0 | 19.99 |
| 2025-10 | 0 | 18.6 |
| 2025-11 | 0 | 16.83 |
| 2025-12 | 0 | 15.93 |
| 2026-01 | 0 | 17 |
| 2026-02 | 0 | 14.12 |
| 2026-03 | 0 | 15.06 |
| 2026-04 | 0 | 11.52 |
| 2026-05 | 0 | 11.51 |
| 2026-06 | 0 | 8.95 |
Failure-mode summaryAI-generated
15 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 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 | 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 |
| 2019-09-10 | Z-0172-2020 | Class I | Terminated | The instrument holder may be sent on a trajectory that is not within the intended target. If it is not corrected, the associated device may be placed incorrectly.Distribution: Nationwide domestic distribution. Foreign distribution to Australia, France, Switzerland, Taiwan, and Vietnam. | 93 | clearance family |
| 2017-02-27 | Z-1754-2017 | Class II | Terminated | Unapproved change made by the supplier.Distribution: Nationwide Distribution to CA, FL, IL, KY, MA, MN, NC, NY, OH, PA, and District of Columbia. | 16 | clearance family |
| 2016-10-11 | Z-2868-2017 | Class II | Terminated | Complaint of the head holder connector locking up mechanically when tightened.Distribution: Worldwide Distribution - US including CA, FL, MA, MN, NC, NY, OH, PA, DC; Foreign - Australia, and France | 20 units (16 US, 4 OUS) | clearance family |
| 2016-07-29 | Z-0116-2018 | Class II | Terminated | Non-conforming product label.Distribution: OH and PA. | 2 devices | clearance family |
| 2016-07-20 | Z-0167-2018 | Class II | Terminated | Communication errors between ROSANNA BRAIN software, MARIO software and the Stubli CS8C controller.Distribution: Worldwide Distribution - US Nationwide in the states of OH, FL, MA, MN, DC, NC, CA, NY, PA and countries of Australia and France | 18 (14 US and 4 OUS) | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2021-02-23 | 3009185973-2021-00062 | Malfunction | Available | catalog number |
| 2021-01-14 | 3009185973-2021-00009 | Malfunction | Available | catalog number |
| 2020-12-22 | 3009185973-2020-00329 | Malfunction | Available | catalog number |
| 2020-10-09 | 3009185973-2020-00257 | Malfunction | Available | catalog number |
| 2020-08-05 | 3009185973-2020-00189 | Injury | Available | catalog number |
| 2020-07-23 | 3009185973-2020-00164 | Malfunction | Available | catalog number |
| 2020-02-21 | 3009185973-2020-00063 | Malfunction | Available | catalog number |
| 2020-02-14 | 3009185973-2020-00049 | Malfunction | Available | catalog number |
| 2020-02-13 | 3009185973-2020-00045 | Malfunction | Available | catalog number |
| 2019-12-17 | 3009185973-2019-00444 | Malfunction | Available | catalog number |
| 2019-10-02 | 3009185973-2019-00337 | Malfunction | Available | catalog number |
| 2019-09-13 | 3009185973-2019-00305 | Malfunction | Available | catalog number |
| 2019-07-02 | 3009185973-2019-00217 | Malfunction | Available | exact di |
| 2019-04-10 | 3009185973-2019-00140 | Malfunction | Available | catalog number |
| 2019-03-06 | 3009185973-2019-00066 | Malfunction | Available | catalog number |
Regulatory clearances
- 510(k)K151359Substantially equivalent (SESE) · 2015-12-18clearance 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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