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.
33 linked reportsInjury 33
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 3.3 |
| 2019-02 | 0 | 2.66 |
| 2019-03 | 0 | 2.83 |
| 2019-04 | 2 | 2.75 |
| 2019-05 | 0 | 2.19 |
| 2019-06 | 0 | 1.9 |
| 2019-07 | 0 | 2.02 |
| 2019-08 | 1 | 2.09 |
| 2019-09 | 1 | 2.42 |
| 2019-10 | 0 | 2.46 |
| 2019-11 | 0 | 1.96 |
| 2019-12 | 2 | 2.32 |
| 2020-01 | 2 | 2.63 |
| 2020-02 | 0 | 2.55 |
| 2020-03 | 0 | 3.32 |
| 2020-04 | 2 | 2.14 |
| 2020-05 | 0 | 2.36 |
| 2020-06 | 0 | 1.89 |
| 2020-07 | 0 | 2.48 |
| 2020-08 | 0 | 1.89 |
| 2020-09 | 2 | 2.22 |
| 2020-10 | 0 | 2.44 |
| 2020-11 | 0 | 2.16 |
| 2020-12 | 2 | 2.16 |
| 2021-01 | 2 | 2.23 |
| 2021-02 | 0 | 1.95 |
| 2021-03 | 2 | 1.98 |
| 2021-04 | 0 | 1.88 |
| 2021-05 | 2 | 1.94 |
| 2021-06 | 0 | 2.35 |
| 2021-07 | 0 | 2.15 |
| 2021-08 | 0 | 1.92 |
| 2021-09 | 0 | 2.11 |
| 2021-10 | 2 | 1.98 |
| 2021-11 | 2 | 2.08 |
| 2021-12 | 0 | 2.29 |
| 2022-01 | 0 | 1.87 |
| 2022-02 | 0 | 2.34 |
| 2022-03 | 0 | 1.87 |
| 2022-04 | 0 | 2.13 |
| 2022-05 | 0 | 1.9 |
| 2022-06 | 2 | 2.02 |
| 2022-07 | 2 | 1.96 |
| 2022-08 | 0 | 2.07 |
| 2022-09 | 0 | 1.96 |
| 2022-10 | 0 | 1.99 |
| 2022-11 | 0 | 2.12 |
| 2022-12 | 0 | 2.02 |
| 2023-01 | 0 | 1.66 |
| 2023-02 | 0 | 1.87 |
| 2023-03 | 0 | 2.02 |
| 2023-04 | 0 | 1.93 |
| 2023-05 | 0 | 2.1 |
| 2023-06 | 0 | 2.12 |
| 2023-07 | 0 | 2.05 |
| 2023-08 | 0 | 2.02 |
| 2023-09 | 0 | 2.03 |
| 2023-10 | 0 | 1.5 |
| 2023-11 | 0 | 1.54 |
| 2023-12 | 0 | 1.57 |
| 2024-01 | 1 | 1.63 |
| 2024-02 | 0 | 1.82 |
| 2024-03 | 1 | 1.96 |
| 2024-04 | 1 | 1.66 |
| 2024-05 | 0 | 2.16 |
| 2024-06 | 0 | 1.89 |
| 2024-07 | 0 | 1.67 |
| 2024-08 | 0 | 1.84 |
| 2024-09 | 0 | 1.96 |
| 2024-10 | 0 | 1.6 |
| 2024-11 | 0 | 1.48 |
| 2024-12 | 0 | 1.48 |
| 2025-01 | 0 | 1.55 |
| 2025-02 | 0 | 1.41 |
| 2025-03 | 0 | 1.62 |
| 2025-04 | 0 | 1.71 |
| 2025-05 | 0 | 1.44 |
| 2025-06 | 0 | 1.69 |
| 2025-07 | 0 | 1.64 |
| 2025-08 | 0 | 1.47 |
| 2025-09 | 0 | 1.77 |
| 2025-10 | 0 | 1.67 |
| 2025-11 | 0 | 1.87 |
| 2025-12 | 0 | 1.85 |
| 2026-01 | 0 | 2.01 |
| 2026-02 | 0 | 1.55 |
| 2026-03 | 0 | 2.14 |
| 2026-04 | 0 | 1.79 |
| 2026-05 | 2 | 1.81 |
| 2026-06 | 0 | 1.65 |
Failure-mode summaryAI-generated
33 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-05-15 | 3005180920-2026-00458 | Injury | Available | exact di |
| 2024-04-30 | 3005180920-2024-00271 | Injury | Available | exact di |
| 2024-03-21 | 3005180920-2024-00105 | Injury | Available | exact di |
| 2024-01-25 | 3005180920-2024-00025 | Injury | Available | exact di |
| 2022-07-21 | 3005180920-2022-00550 | Injury | Available | exact di |
| 2022-06-21 | 3005180920-2022-00472 | Injury | Available | exact di |
| 2021-11-09 | 3005180920-2021-00873 | Injury | Available | exact di |
| 2021-10-28 | 3005180920-2021-00828 | Injury | Available | exact di |
| 2021-05-31 | 3005180920-2021-00445 | Injury | Available | exact di |
| 2021-03-12 | 3005180920-2021-00195 | Injury | Available | exact di |
| 2021-01-28 | 3005180920-2021-00073 | Injury | Available | exact di |
| 2020-12-21 | 3005180920-2020-00908 | Injury | Available | exact di |
| 2020-09-29 | 3005180920-2020-00659 | Injury | Available | exact di |
| 2020-04-07 | 3005180920-2020-00217 | Injury | Available | exact di |
| 2020-01-17 | 3005180920-2019-01153 | Injury | Available | exact di |
Showing the most recent 21 of 33 linked reports.
Showing 1–15 of 21
Regulatory clearances
Predicate lineage
K082792
Cited as predicate by: K091967, K092265, K093944, K103352, K103721, K112115, K120531, K121011, K122911, K171595, K181254, K201673, K203041, K250450
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 |
|---|---|---|---|---|
| 2024-11-19 | VAI | Voluntary action indicated | Medacta International, SA | 1 |
| 2024-11-19 | VAI | Voluntary action indicated | Medacta International SA | 0 |
| 2024-11-19 | VAI | Voluntary action indicated | Medacta International, SA | 1 |
| 2024-11-19 | VAI | Voluntary action indicated | Medacta International SA | 0 |
| 2017-06-19 | VAI | Voluntary action indicated | Medacta International SA | 0 |
| 2017-06-19 | VAI | Voluntary action indicated | Medacta International SA | 0 |
| 2017-02-17 | VAI | Voluntary action indicated | Parcus Medical, LLC | 2 |
| 2015-02-05 | OAI | Official action indicated | Medacta International SA | 8 |
| 2015-02-05 | OAI | Official action indicated | Medacta International SA | 8 |
| 2013-08-16 | VAI | Voluntary action indicated | Parcus Medical, LLC | 1 |
| 2010-01-28 | VAI | Voluntary action indicated | Medacta International SA | 0 |
| 2010-01-28 | VAI | Voluntary action indicated | Medacta International SA | 0 |
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