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.
25 linked reportsInjury 24Malfunction 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.1 |
| 2019-02 | 0 | 2.32 |
| 2019-03 | 0 | 1.9 |
| 2019-04 | 0 | 2.37 |
| 2019-05 | 1 | 2.59 |
| 2019-06 | 0 | 1.9 |
| 2019-07 | 0 | 2.22 |
| 2019-08 | 0 | 2.61 |
| 2019-09 | 0 | 1.98 |
| 2019-10 | 0 | 2.02 |
| 2019-11 | 0 | 1.86 |
| 2019-12 | 0 | 1.81 |
| 2020-01 | 0 | 2.03 |
| 2020-02 | 0 | 1.99 |
| 2020-03 | 0 | 2.77 |
| 2020-04 | 0 | 1.94 |
| 2020-05 | 0 | 1.92 |
| 2020-06 | 0 | 2.12 |
| 2020-07 | 0 | 2.78 |
| 2020-08 | 0 | 1.9 |
| 2020-09 | 0 | 2.01 |
| 2020-10 | 0 | 2.32 |
| 2020-11 | 0 | 1.97 |
| 2020-12 | 0 | 1.94 |
| 2021-01 | 0 | 2.64 |
| 2021-02 | 0 | 2.25 |
| 2021-03 | 0 | 2.39 |
| 2021-04 | 0 | 2.35 |
| 2021-05 | 0 | 2.25 |
| 2021-06 | 0 | 2.32 |
| 2021-07 | 0 | 2.38 |
| 2021-08 | 0 | 2.45 |
| 2021-09 | 0 | 2.35 |
| 2021-10 | 0 | 2.85 |
| 2021-11 | 0 | 2.36 |
| 2021-12 | 0 | 3.62 |
| 2022-01 | 0 | 3.42 |
| 2022-02 | 0 | 2.83 |
| 2022-03 | 0 | 3.44 |
| 2022-04 | 2 | 3.11 |
| 2022-05 | 0 | 2.47 |
| 2022-06 | 2 | 2.58 |
| 2022-07 | 0 | 2.41 |
| 2022-08 | 0 | 2.61 |
| 2022-09 | 0 | 2.37 |
| 2022-10 | 0 | 2.45 |
| 2022-11 | 0 | 2.38 |
| 2022-12 | 0 | 2.59 |
| 2023-01 | 0 | 2.04 |
| 2023-02 | 0 | 2.27 |
| 2023-03 | 0 | 2.22 |
| 2023-04 | 2 | 2.56 |
| 2023-05 | 2 | 2.29 |
| 2023-06 | 0 | 2.39 |
| 2023-07 | 0 | 2.16 |
| 2023-08 | 0 | 1.92 |
| 2023-09 | 0 | 1.71 |
| 2023-10 | 0 | 1.74 |
| 2023-11 | 0 | 1.84 |
| 2023-12 | 0 | 1.52 |
| 2024-01 | 0 | 1.74 |
| 2024-02 | 0 | 2.03 |
| 2024-03 | 0 | 1.8 |
| 2024-04 | 2 | 1.99 |
| 2024-05 | 0 | 1.73 |
| 2024-06 | 0 | 1.88 |
| 2024-07 | 0 | 1.69 |
| 2024-08 | 0 | 1.77 |
| 2024-09 | 1 | 1.77 |
| 2024-10 | 0 | 1.9 |
| 2024-11 | 0 | 1.72 |
| 2024-12 | 0 | 1.71 |
| 2025-01 | 0 | 1.77 |
| 2025-02 | 0 | 1.77 |
| 2025-03 | 2 | 2.04 |
| 2025-04 | 0 | 1.87 |
| 2025-05 | 0 | 1.94 |
| 2025-06 | 0 | 2.13 |
| 2025-07 | 4 | 1.89 |
| 2025-08 | 0 | 1.73 |
| 2025-09 | 2 | 1.54 |
| 2025-10 | 1 | 1.77 |
| 2025-11 | 0 | 1.78 |
| 2025-12 | 0 | 2.29 |
| 2026-01 | 2 | 2.02 |
| 2026-02 | 0 | 1.93 |
| 2026-03 | 0 | 1.88 |
| 2026-04 | 0 | 1.78 |
| 2026-05 | 2 | 1.86 |
| 2026-06 | 0 | 1.95 |
Failure-mode summaryAI-generated
25 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-05-05 | 3005180920-2026-00381 | Injury | Available | exact di |
| 2026-01-29 | 3005180920-2026-00040 | Injury | Available | exact di |
| 2025-10-01 | 3005180920-2025-00913 | Injury | Available | model number |
| 2025-09-10 | 3005180920-2025-00834 | Injury | Available | exact di |
| 2025-07-23 | 3005180920-2025-00720 | Injury | Available | exact di |
| 2025-07-08 | 3005180920-2025-00595 | Injury | Available | exact di |
| 2025-03-03 | 3005180920-2025-00141 | Injury | Available | exact di |
| 2024-09-06 | 3005180920-2024-00693 | Injury | Available | exact di |
| 2024-04-10 | 3005180920-2024-00238 | Malfunction | Available | exact di |
| 2024-04-04 | 3005180920-2024-00195 | Injury | Available | exact di |
| 2023-05-24 | 3005180920-2023-00359 | Injury | Available | exact di |
| 2023-04-14 | 3005180920-2023-00245 | Injury | Available | exact di |
| 2022-06-13 | 3005180920-2022-00447 | Injury | Available | exact di |
| 2022-04-20 | 3005180920-2022-00269 | Injury | Available | exact di |
| 2019-05-16 | 3005180920-2019-00383 | Injury | Available | exact di |
Showing the most recent 15 of 25 linked reports.
Regulatory clearances
Predicate lineage
- K170452
Cited as predicate by: K170910, K171058, K180089, K190738, K191433, K193175, K202568, K203755, K210207, K213459, K231911, K242232, K250338, K250644, K251737
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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