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.
13 linked reportsInjury 13
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 4.67 |
| 2019-02 | 0 | 9.4 |
| 2019-03 | 0 | 7.11 |
| 2019-04 | 0 | 6.8 |
| 2019-05 | 0 | 11 |
| 2019-06 | 0 | 8.82 |
| 2019-07 | 0 | 10.67 |
| 2019-08 | 0 | 15.7 |
| 2019-09 | 0 | 8.56 |
| 2019-10 | 0 | 5.44 |
| 2019-11 | 0 | 6.78 |
| 2019-12 | 0 | 10.33 |
| 2020-01 | 0 | 4.11 |
| 2020-02 | 0 | 8.23 |
| 2020-03 | 0 | 8.27 |
| 2020-04 | 0 | 9.77 |
| 2020-05 | 0 | 5.38 |
| 2020-06 | 0 | 2.45 |
| 2020-07 | 0 | 3.25 |
| 2020-08 | 0 | 3.06 |
| 2020-09 | 0 | 2.6 |
| 2020-10 | 0 | 3.1 |
| 2020-11 | 0 | 2.31 |
| 2020-12 | 0 | 3.42 |
| 2021-01 | 0 | 2.69 |
| 2021-02 | 0 | 2.82 |
| 2021-03 | 0 | 3.46 |
| 2021-04 | 0 | 3.18 |
| 2021-05 | 0 | 3.67 |
| 2021-06 | 0 | 3.32 |
| 2021-07 | 0 | 4.38 |
| 2021-08 | 0 | 3.8 |
| 2021-09 | 0 | 2.2 |
| 2021-10 | 0 | 2.88 |
| 2021-11 | 0 | 2.87 |
| 2021-12 | 0 | 4.08 |
| 2022-01 | 0 | 5 |
| 2022-02 | 0 | 2.5 |
| 2022-03 | 1 | 3 |
| 2022-04 | 0 | 2 |
| 2022-05 | 0 | 1.58 |
| 2022-06 | 0 | 3.5 |
| 2022-07 | 0 | 2.93 |
| 2022-08 | 0 | 3.15 |
| 2022-09 | 0 | 5 |
| 2022-10 | 0 | 3 |
| 2022-11 | 0 | 1.94 |
| 2022-12 | 0 | 2.14 |
| 2023-01 | 0 | 2.27 |
| 2023-02 | 2 | 2.27 |
| 2023-03 | 0 | 2.39 |
| 2023-04 | 0 | 2.14 |
| 2023-05 | 1 | 1.58 |
| 2023-06 | 0 | 2.79 |
| 2023-07 | 0 | 2.56 |
| 2023-08 | 0 | 2.11 |
| 2023-09 | 0 | 2 |
| 2023-10 | 0 | 3.58 |
| 2023-11 | 0 | 2.1 |
| 2023-12 | 0 | 1.87 |
| 2024-01 | 1 | 2 |
| 2024-02 | 0 | 2.76 |
| 2024-03 | 1 | 2.33 |
| 2024-04 | 0 | 4.53 |
| 2024-05 | 0 | 2.42 |
| 2024-06 | 2 | 2.44 |
| 2024-07 | 0 | 2.95 |
| 2024-08 | 0 | 3.22 |
| 2024-09 | 0 | 3.36 |
| 2024-10 | 0 | 3.09 |
| 2024-11 | 0 | 3.28 |
| 2024-12 | 0 | 2.28 |
| 2025-01 | 3 | 6.17 |
| 2025-02 | 0 | 6.5 |
| 2025-03 | 0 | 2.58 |
| 2025-04 | 0 | 2.36 |
| 2025-05 | 0 | 2.35 |
| 2025-06 | 0 | 2.8 |
| 2025-07 | 0 | 2.79 |
| 2025-08 | 0 | 3.78 |
| 2025-09 | 0 | 2.86 |
| 2025-10 | 0 | 9.4 |
| 2025-11 | 1 | 2.83 |
| 2025-12 | 0 | 6.03 |
| 2026-01 | 0 | 6.9 |
| 2026-02 | 0 | 3.84 |
| 2026-03 | 0 | 13.11 |
| 2026-04 | 0 | 11.4 |
| 2026-05 | 0 | 16.65 |
| 2026-06 | 1 | 9.38 |
Failure-mode summaryAI-generated
13 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-22 | 1724955-2026-00004 | Injury | Available | exact di |
| 2025-11-12 | 1724955-2025-00009 | Injury | Available | exact di |
| 2025-01-14 | 1724955-2025-00001 | Injury | Available | exact di |
| 2025-01-14 | 1724955-2025-00002 | Injury | Available | exact di |
| 2025-01-14 | 1724955-2025-00003 | Injury | Available | exact di |
| 2024-06-26 | 1724955-2024-00007 | Injury | Available | exact di |
| 2024-06-10 | 1724955-2024-00005 | Injury | Available | exact di |
| 2024-03-01 | 1724955-2024-00001 | Injury | Available | exact di |
| 2024-01-03 | 1724955-2023-00015 | Injury | Available | exact di |
| 2023-05-12 | 1724955-2023-00011 | Injury | Available | exact di |
| 2023-02-09 | 1724955-2023-00005 | Injury | Available | exact di |
| 2023-02-08 | 1724955-2023-00004 | Injury | Available | exact di |
| 2022-03-08 | 1724955-2022-00004 | Injury | Available | exact di |
Regulatory clearances
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 |
|---|---|---|---|---|
| 2023-09-15 | NAI | No action indicated | Medical Modeling, a 3D Systems Company | 0 |
| 2021-06-15 | NAI | No action indicated | Medical Modeling, a 3D Systems Company | 0 |
| 2017-05-05 | NAI | No action indicated | Medical Modeling, a 3D Systems Company | 0 |
| 2015-06-03 | NAI | No action indicated | 3D Systems, Inc. | 0 |
| 2014-04-25 | NAI | No action indicated | Medical Modeling, a 3D Systems Company | 0 |
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