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.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.11 |
| 2019-02 | 0 | 1.6 |
| 2019-03 | 0 | 1.65 |
| 2019-04 | 0 | 2.23 |
| 2019-05 | 0 | 1.75 |
| 2019-06 | 0 | 1.81 |
| 2019-07 | 0 | 2.06 |
| 2019-08 | 0 | 2.03 |
| 2019-09 | 0 | 1.75 |
| 2019-10 | 0 | 1.69 |
| 2019-11 | 0 | 1.96 |
| 2019-12 | 0 | 2.52 |
| 2020-01 | 0 | 2.55 |
| 2020-02 | 0 | 2.13 |
| 2020-03 | 0 | 1.9 |
| 2020-04 | 0 | 1.87 |
| 2020-05 | 0 | 1.75 |
| 2020-06 | 0 | 2.06 |
| 2020-07 | 0 | 2.67 |
| 2020-08 | 0 | 2.5 |
| 2020-09 | 0 | 2.44 |
| 2020-10 | 0 | 2.22 |
| 2020-11 | 0 | 2.83 |
| 2020-12 | 0 | 2.48 |
| 2021-01 | 0 | 1.85 |
| 2021-02 | 0 | 2.29 |
| 2021-03 | 0 | 2.59 |
| 2021-04 | 0 | 2.7 |
| 2021-05 | 0 | 2.4 |
| 2021-06 | 0 | 2.2 |
| 2021-07 | 0 | 2.29 |
| 2021-08 | 0 | 2.07 |
| 2021-09 | 0 | 2.36 |
| 2021-10 | 0 | 2.08 |
| 2021-11 | 0 | 2.26 |
| 2021-12 | 0 | 2.35 |
| 2022-01 | 0 | 2.94 |
| 2022-02 | 0 | 2.2 |
| 2022-03 | 0 | 2.01 |
| 2022-04 | 0 | 1.94 |
| 2022-05 | 0 | 2.37 |
| 2022-06 | 0 | 2.22 |
| 2022-07 | 0 | 2.18 |
| 2022-08 | 0 | 2.48 |
| 2022-09 | 0 | 2.88 |
| 2022-10 | 0 | 3 |
| 2022-11 | 0 | 2.99 |
| 2022-12 | 0 | 5.49 |
| 2023-01 | 2 | 2.72 |
| 2023-02 | 0 | 2.85 |
| 2023-03 | 0 | 3.08 |
| 2023-04 | 0 | 2.76 |
| 2023-05 | 0 | 3.3 |
| 2023-06 | 0 | 2.94 |
| 2023-07 | 0 | 2.28 |
| 2023-08 | 0 | 2.16 |
| 2023-09 | 0 | 2.02 |
| 2023-10 | 0 | 2.14 |
| 2023-11 | 0 | 1.87 |
| 2023-12 | 0 | 2.44 |
| 2024-01 | 0 | 2.76 |
| 2024-02 | 0 | 1.81 |
| 2024-03 | 0 | 2.34 |
| 2024-04 | 0 | 2.12 |
| 2024-05 | 0 | 2.3 |
| 2024-06 | 0 | 2.26 |
| 2024-07 | 0 | 2.46 |
| 2024-08 | 0 | 2.14 |
| 2024-09 | 0 | 2.15 |
| 2024-10 | 0 | 2.19 |
| 2024-11 | 0 | 2.05 |
| 2024-12 | 0 | 2.76 |
| 2025-01 | 0 | 2.2 |
| 2025-02 | 0 | 2.18 |
| 2025-03 | 0 | 2.06 |
| 2025-04 | 0 | 2.54 |
| 2025-05 | 0 | 2.49 |
| 2025-06 | 0 | 2.01 |
| 2025-07 | 0 | 2.14 |
| 2025-08 | 0 | 2.39 |
| 2025-09 | 0 | 2.07 |
| 2025-10 | 0 | 2.47 |
| 2025-11 | 0 | 2.05 |
| 2025-12 | 0 | 2.73 |
| 2026-01 | 0 | 2.06 |
| 2026-02 | 0 | 2.37 |
| 2026-03 | 0 | 2.62 |
| 2026-04 | 0 | 2.17 |
| 2026-05 | 0 | 2.56 |
| 2026-06 | 0 | 2.32 |
2 linked report narratives available — no AI summary generated yet.
No recalls linked.
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2023-01-23 | 8030965-2023-00772 | Injury | Available | exact di |
Showing the most recent 1 of 2 linked reports.
Predicate lineage
Cited as predicate by: K092754, K110472, K112240, K123702, K123890, K124027, K141549, K142057, K142442, K150017, K150693, K151462, K152237, K152757, K153656, K153716, K161616, K161755, K162121, K162733, K162825, K170038, K170475, K171320, K171595, K173201, K180818, K181881, K183119, K190025, K190580, K191748, K210146, K210402, K211449, K211496, K211785, K212962, K220274, K222282, K230053, K230226, K231829, K231951, K232605, K232878, K241813, K242431, K243838, K250647, K250894
- K161616
Cited as predicate by: K160553, K172872, K190830, K192096, K192745, K193660, K200043, K201728, K211435, K212755, K221090, K222967, K230867, K231272, K233008, K241504, K243943, K252699, K253488
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.
| 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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