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.
9 linked reportsMalfunction 9
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 11.14 |
| 2019-02 | 0 | 6.96 |
| 2019-03 | 0 | 9 |
| 2019-04 | 0 | 12.39 |
| 2019-05 | 0 | 11.21 |
| 2019-06 | 0 | 8.12 |
| 2019-07 | 0 | 9.87 |
| 2019-08 | 0 | 10.86 |
| 2019-09 | 0 | 7.18 |
| 2019-10 | 0 | 7.03 |
| 2019-11 | 0 | 6.75 |
| 2019-12 | 0 | 7.21 |
| 2020-01 | 0 | 7.14 |
| 2020-02 | 0 | 8.11 |
| 2020-03 | 0 | 9.94 |
| 2020-04 | 0 | 9 |
| 2020-05 | 0 | 8.87 |
| 2020-06 | 0 | 7.54 |
| 2020-07 | 0 | 7.32 |
| 2020-08 | 0 | 7 |
| 2020-09 | 0 | 5.97 |
| 2020-10 | 0 | 6.37 |
| 2020-11 | 0 | 5.02 |
| 2020-12 | 0 | 4.96 |
| 2021-01 | 0 | 5.22 |
| 2021-02 | 0 | 6.05 |
| 2021-03 | 0 | 5.96 |
| 2021-04 | 0 | 7.74 |
| 2021-05 | 0 | 7.04 |
| 2021-06 | 0 | 8.24 |
| 2021-07 | 0 | 4.61 |
| 2021-08 | 0 | 8.76 |
| 2021-09 | 0 | 9.57 |
| 2021-10 | 0 | 7.32 |
| 2021-11 | 0 | 8.45 |
| 2021-12 | 0 | 7.84 |
| 2022-01 | 0 | 6.8 |
| 2022-02 | 0 | 6.7 |
| 2022-03 | 0 | 7.88 |
| 2022-04 | 0 | 7.41 |
| 2022-05 | 0 | 9.84 |
| 2022-06 | 0 | 7.29 |
| 2022-07 | 0 | 6.78 |
| 2022-08 | 0 | 7.57 |
| 2022-09 | 0 | 7.46 |
| 2022-10 | 0 | 20.57 |
| 2022-11 | 0 | 38.1 |
| 2022-12 | 0 | 36.69 |
| 2023-01 | 0 | 47.93 |
| 2023-02 | 0 | 32.99 |
| 2023-03 | 0 | 57.63 |
| 2023-04 | 0 | 37.39 |
| 2023-05 | 0 | 43.25 |
| 2023-06 | 0 | 35.89 |
| 2023-07 | 0 | 25.98 |
| 2023-08 | 0 | 29.28 |
| 2023-09 | 0 | 40.35 |
| 2023-10 | 0 | 35.02 |
| 2023-11 | 0 | 40.46 |
| 2023-12 | 0 | 43.76 |
| 2024-01 | 0 | 38.19 |
| 2024-02 | 0 | 57.14 |
| 2024-03 | 0 | 37.49 |
| 2024-04 | 0 | 35.77 |
| 2024-05 | 0 | 37.21 |
| 2024-06 | 0 | 33.37 |
| 2024-07 | 6 | 36.1 |
| 2024-08 | 0 | 46.64 |
| 2024-09 | 0 | 47.79 |
| 2024-10 | 0 | 41.04 |
| 2024-11 | 0 | 38.81 |
| 2024-12 | 0 | 39.34 |
| 2025-01 | 0 | 39 |
| 2025-02 | 0 | 51.09 |
| 2025-03 | 0 | 42.53 |
| 2025-04 | 0 | 54.92 |
| 2025-05 | 0 | 60.56 |
| 2025-06 | 0 | 56.7 |
| 2025-07 | 0 | 64.05 |
| 2025-08 | 0 | 86.5 |
| 2025-09 | 0 | 152.33 |
| 2025-10 | 0 | 137.96 |
| 2025-11 | 0 | 93.77 |
| 2025-12 | 0 | 40.6 |
| 2026-01 | 0 | 36.26 |
| 2026-02 | 2 | 27.67 |
| 2026-03 | 0 | 28.75 |
| 2026-04 | 1 | 26.01 |
| 2026-05 | 0 | 27.96 |
| 2026-06 | 0 | 24.75 |
Failure-mode summaryAI-generated
9 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-04-22 | MW5187121 | Malfunction | Available | model number |
| 2026-02-03 | 3004142400-2026-00029 | Malfunction | Available | exact di |
| 2024-07-25 | 3004142400-2024-00179 | Malfunction | Available | exact di |
| 2024-07-25 | 3004142400-2024-00180 | Malfunction | Available | exact di |
| 2024-07-25 | 3004142400-2024-00181 | Malfunction | Available | exact di |
Showing the most recent 5 of 9 linked reports.
Regulatory clearances
- 510(k)K210912Substantially equivalent (SESE) · 2021-08-12clearance 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 |
|---|---|---|---|---|
| 2025-10-16 | VAI | Voluntary action indicated | Globus Medical, Inc. | 1 |
| 2025-10-16 | VAI | Voluntary action indicated | Globus Medical, Inc. | 1 |
| 2025-08-13 | OAI | Official action indicated | Nevro Corporation | 6 |
| 2025-03-25 | NAI | No action indicated | Nuvasive Manufacturing LLC. | 0 |
| 2024-07-15 | WL | Warning Letter | Globus Medical, Inc. | — |
| 2024-07-15 | WL | Warning Letter | Globus Medical, Inc. | — |
| 2024-03-07 | OAI | Official action indicated | Globus Medical, Inc. | 6 |
| 2024-03-07 | OAI | Official action indicated | Globus Medical, Inc. | 6 |
| 2023-12-20 | VAI | Voluntary action indicated | Nevro Corporation | 1 |
| 2022-07-29 | NAI | No action indicated | Nevro Medical SRL | 0 |
| 2022-04-26 | NAI | No action indicated | Nevro Corporation | 0 |
| 2019-10-23 | NAI | No action indicated | Globus Medical, Inc. | 0 |
| 2019-10-23 | NAI | No action indicated | Globus Medical, Inc. | 0 |
| 2019-09-27 | VAI | Voluntary action indicated | Globus Medical, Inc. | 7 |
| 2019-09-27 | VAI | Voluntary action indicated | Globus Medical, Inc. | 7 |
| 2019-03-21 | NAI | No action indicated | Nevro Corporation | 0 |
| 2019-02-13 | VAI | Voluntary action indicated | Globus Medical, Inc. | 2 |
| 2019-02-13 | VAI | Voluntary action indicated | Globus Medical, Inc. | 2 |
| 2018-03-16 | NAI | No action indicated | Nevro Corporation | 0 |
| 2017-11-03 | VAI | Voluntary action indicated | Nevro Corporation | 5 |
| 2017-09-25 | NAI | No action indicated | Globus Medical, Inc. | 0 |
| 2017-09-25 | NAI | No action indicated | Globus Medical, Inc. | 0 |
| 2013-09-26 | WL | Warning Letter | Globus Medical, Inc. | — |
| 2013-09-26 | WL | Warning Letter | Globus Medical, Inc. | — |
Similar devices
- IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE GEMSS MEDICAL SYSTEMS CO.,LTD.
- "12"" II Tube Drape (36X36)" ADVANCE MEDICAL DESIGNS, INC.
- "9600/9800/9900 Super C 12""" ADVANCE MEDICAL DESIGNS, INC.
- 0909FCB Rayence Co., Ltd.
- 0909FCC Rayence Co., Ltd.
- 0909FCC-HS Rayence Co., Ltd.
- 0909FCE Rayence Co., Ltd.
- 0909FCE-HS Rayence Co., Ltd.
- 2D Perfusion Philips Medical Systems Nederland B.V.
- 2D Quantitative Analysis Philips Medical Systems Nederland B.V.
- 3D Imaging Set SPX1 ECENTIAL ROBOTICS
- 3D Imaging Set SPX1 ECENTIAL ROBOTICS
Select up to two to place side-by-side with this device.