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.
2 linked reportsInjury 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-11 | 0 | 1 |
| 2019-12 | 0 | 3 |
| 2020-01 | 0 | 4 |
| 2020-07 | 0 | 1 |
| 2020-09 | 0 | 2 |
| 2021-04 | 0 | 1 |
| 2021-05 | 0 | 1 |
| 2021-06 | 0 | 1 |
| 2022-03 | 2 | 2 |
| 2022-06 | 0 | 1 |
| 2022-07 | 0 | 2.67 |
| 2022-11 | 0 | 1 |
| 2022-12 | 0 | 1 |
| 2023-05 | 0 | 1 |
| 2023-10 | 0 | 1 |
| 2024-05 | 0 | 1 |
| 2024-08 | 0 | 1 |
| 2024-10 | 0 | 1 |
| 2025-08 | 0 | 2 |
| 2025-11 | 0 | 1 |
| 2025-12 | 0 | 1 |
| 2026-03 | 0 | 1 |
| 2026-04 | 0 | 1 |
Failure-mode summaryAI-generated
2 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2022-03-08 | 1724955-2022-00003 | Injury | Available | exact di |
Showing the most recent 1 of 2 linked reports.
Regulatory clearances
- 510(k)K211244Substantially equivalent (SESE) · 2021-11-10clearance 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 |
|---|---|---|---|---|
| 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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