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.
1 linked reportInjury 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.23 |
| 2019-02 | 0 | 2.91 |
| 2019-03 | 0 | 1.92 |
| 2019-04 | 0 | 2.5 |
| 2019-05 | 0 | 2.53 |
| 2019-06 | 0 | 2.17 |
| 2019-07 | 0 | 2.79 |
| 2019-08 | 0 | 2.33 |
| 2019-09 | 0 | 2.54 |
| 2019-10 | 0 | 3.41 |
| 2019-11 | 0 | 2.58 |
| 2019-12 | 0 | 3.04 |
| 2020-01 | 0 | 2.62 |
| 2020-02 | 0 | 2.09 |
| 2020-03 | 0 | 2.57 |
| 2020-04 | 0 | 2.06 |
| 2020-05 | 0 | 2.2 |
| 2020-06 | 0 | 2.79 |
| 2020-07 | 0 | 3.39 |
| 2020-08 | 0 | 3.07 |
| 2020-09 | 1 | 2.93 |
| 2020-10 | 0 | 3.76 |
| 2020-11 | 0 | 4.24 |
| 2020-12 | 0 | 3.5 |
| 2021-01 | 0 | 4.32 |
| 2021-02 | 0 | 3.6 |
| 2021-03 | 0 | 3.68 |
| 2021-04 | 0 | 3.36 |
| 2021-05 | 0 | 3.3 |
| 2021-06 | 0 | 3.03 |
| 2021-07 | 0 | 3.23 |
| 2021-08 | 0 | 2.55 |
| 2021-09 | 0 | 3.23 |
| 2021-10 | 0 | 2.63 |
| 2021-11 | 0 | 3.33 |
| 2021-12 | 0 | 3.57 |
| 2022-01 | 0 | 3.65 |
| 2022-02 | 0 | 3.27 |
| 2022-03 | 0 | 2.96 |
| 2022-04 | 0 | 3.21 |
| 2022-05 | 0 | 2.79 |
| 2022-06 | 0 | 2.84 |
| 2022-07 | 0 | 3.37 |
| 2022-08 | 0 | 3.14 |
| 2022-09 | 0 | 4.22 |
| 2022-10 | 0 | 2.9 |
| 2022-11 | 0 | 3.55 |
| 2022-12 | 0 | 3.25 |
| 2023-01 | 0 | 3.38 |
| 2023-02 | 0 | 3.3 |
| 2023-03 | 0 | 3.84 |
| 2023-04 | 0 | 3.01 |
| 2023-05 | 0 | 4.16 |
| 2023-06 | 0 | 3.44 |
| 2023-07 | 0 | 3.5 |
| 2023-08 | 0 | 2.86 |
| 2023-09 | 0 | 2.47 |
| 2023-10 | 0 | 2.66 |
| 2023-11 | 0 | 2.44 |
| 2023-12 | 0 | 2.29 |
| 2024-01 | 0 | 2.51 |
| 2024-02 | 0 | 2.85 |
| 2024-03 | 0 | 2.54 |
| 2024-04 | 0 | 2.29 |
| 2024-05 | 0 | 3.19 |
| 2024-06 | 0 | 2.94 |
| 2024-07 | 0 | 3.07 |
| 2024-08 | 0 | 2.21 |
| 2024-09 | 0 | 3.77 |
| 2024-10 | 0 | 2.7 |
| 2024-11 | 0 | 2.53 |
| 2024-12 | 0 | 1.93 |
| 2025-01 | 0 | 5.71 |
| 2025-02 | 0 | 4.23 |
| 2025-03 | 0 | 2.71 |
| 2025-04 | 0 | 2.89 |
| 2025-05 | 0 | 3.18 |
| 2025-06 | 0 | 2.6 |
| 2025-07 | 0 | 2.97 |
| 2025-08 | 0 | 2.94 |
| 2025-09 | 0 | 2.42 |
| 2025-10 | 0 | 2.19 |
| 2025-11 | 0 | 2.72 |
| 2025-12 | 0 | 3.24 |
| 2026-01 | 0 | 3.03 |
| 2026-02 | 0 | 2.44 |
| 2026-03 | 0 | 2.65 |
| 2026-04 | 0 | 2.94 |
| 2026-05 | 0 | 2.92 |
| 2026-06 | 0 | 3.24 |
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2020-09-15 | 8030965-2020-07013 | Injury | Available | exact di |
Regulatory clearances
Predicate lineage
K950384
Cited as predicate by: K122455
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 |
|---|---|---|---|---|
| 2017-08-08 | NAI | No action indicated | Synthes GmbH | 0 |
| 2017-01-18 | NAI | No action indicated | Synthes (USA), LLC | 0 |
| 2015-05-08 | VAI | Voluntary action indicated | Synthes (USA), LLC | 2 |
| 2013-11-13 | VAI | Voluntary action indicated | Synthes, Inc. | 1 |
| 2013-05-16 | NAI | No action indicated | Synthes, Inc. | 0 |
| 2012-10-19 | VAI | Voluntary action indicated | Synthes, Inc. | 1 |
| 2012-02-16 | WL | Warning Letter | Synthes, Inc. | — |
| 2012-02-01 | NAI | No action indicated | Synthes (USA), LLC | 0 |
| 2011-09-15 | OAI | Official action indicated | Synthes, Inc. | 10 |
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