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 |
| 2019-02 | 0 | 1.57 |
| 2019-03 | 0 | 1.71 |
| 2019-04 | 0 | 2.26 |
| 2019-05 | 1 | 1.69 |
| 2019-06 | 0 | 1.72 |
| 2019-07 | 1 | 1.93 |
| 2019-08 | 0 | 1.83 |
| 2019-09 | 0 | 1.69 |
| 2019-10 | 0 | 1.58 |
| 2019-11 | 0 | 1.82 |
| 2019-12 | 0 | 2.19 |
| 2020-01 | 1 | 2.33 |
| 2020-02 | 0 | 1.48 |
| 2020-03 | 1 | 1.74 |
| 2020-04 | 0 | 1.84 |
| 2020-05 | 0 | 1.71 |
| 2020-06 | 0 | 2 |
| 2020-07 | 0 | 2.27 |
| 2020-08 | 0 | 2.39 |
| 2020-09 | 0 | 2.56 |
| 2020-10 | 0 | 2.12 |
| 2020-11 | 0 | 2.53 |
| 2020-12 | 0 | 2.37 |
| 2021-01 | 0 | 1.8 |
| 2021-02 | 0 | 2.19 |
| 2021-03 | 0 | 2.41 |
| 2021-04 | 0 | 2.72 |
| 2021-05 | 0 | 2.55 |
| 2021-06 | 0 | 2.11 |
| 2021-07 | 0 | 2.22 |
| 2021-08 | 0 | 1.94 |
| 2021-09 | 0 | 2.18 |
| 2021-10 | 0 | 1.98 |
| 2021-11 | 0 | 2.26 |
| 2021-12 | 0 | 2.23 |
| 2022-01 | 0 | 2.83 |
| 2022-02 | 0 | 2.22 |
| 2022-03 | 0 | 1.91 |
| 2022-04 | 0 | 2.01 |
| 2022-05 | 0 | 2.31 |
| 2022-06 | 0 | 2.27 |
| 2022-07 | 0 | 2.2 |
| 2022-08 | 0 | 2.28 |
| 2022-09 | 0 | 2.68 |
| 2022-10 | 0 | 3 |
| 2022-11 | 0 | 3.02 |
| 2022-12 | 0 | 4.35 |
| 2023-01 | 0 | 2.66 |
| 2023-02 | 0 | 2.69 |
| 2023-03 | 0 | 2.95 |
| 2023-04 | 0 | 2.85 |
| 2023-05 | 2 | 3.55 |
| 2023-06 | 0 | 2.89 |
| 2023-07 | 0 | 2.25 |
| 2023-08 | 0 | 2.11 |
| 2023-09 | 0 | 2.06 |
| 2023-10 | 0 | 2.2 |
| 2023-11 | 0 | 1.89 |
| 2023-12 | 0 | 2.37 |
| 2024-01 | 0 | 2.45 |
| 2024-02 | 0 | 1.8 |
| 2024-03 | 0 | 2.08 |
| 2024-04 | 0 | 2.1 |
| 2024-05 | 0 | 2.11 |
| 2024-06 | 0 | 2.25 |
| 2024-07 | 0 | 2.31 |
| 2024-08 | 0 | 2.14 |
| 2024-09 | 0 | 1.91 |
| 2024-10 | 0 | 2.22 |
| 2024-11 | 0 | 1.89 |
| 2024-12 | 0 | 2.84 |
| 2025-01 | 0 | 1.97 |
| 2025-02 | 0 | 2.02 |
| 2025-03 | 0 | 2.28 |
| 2025-04 | 0 | 2.28 |
| 2025-05 | 0 | 2.31 |
| 2025-06 | 0 | 1.84 |
| 2025-07 | 0 | 2.1 |
| 2025-08 | 0 | 2.19 |
| 2025-09 | 0 | 1.94 |
| 2025-10 | 0 | 2.32 |
| 2025-11 | 0 | 1.98 |
| 2025-12 | 0 | 2.56 |
| 2026-01 | 0 | 1.9 |
| 2026-02 | 0 | 2.16 |
| 2026-03 | 0 | 2.69 |
| 2026-04 | 0 | 2.17 |
| 2026-05 | 0 | 2.45 |
| 2026-06 | 0 | 2.13 |
6 linked report narratives available — no AI summary generated yet.
No recalls linked.
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2023-05-19 | 8030965-2023-06317 | Malfunction | Available | exact di |
| 2020-03-18 | 2939274-2020-01336 | Injury | Available | exact di |
| 2020-01-08 | 2939274-2020-00101 | Injury | Available | exact di |
| 2019-07-16 | 2939274-2019-59194 | Injury | Available | exact di |
| 2019-05-02 | 2939274-2019-57784 | Injury | Available | exact di |
Showing the most recent 5 of 6 linked reports.
Predicate lineage
Cited as predicate by: K101536, K103002, K103513, K111540, K112583, K112663, K113652, K113760, K120651, K120717, K120807, K120854, K121601, K122936, K130009, K133452, K133541, K140216, K140431, K140607, K141680, K143061, K150561, K152289, K152732, K153374, K153716, K160553, K161048, K161894, K162078, K163044, K163361, K163383, K170727, K170887, K171285, K181035, K181587, K191118, K191793, K193554, K193633, K193639, K201321, K223150, K230623, K231213, K233665, K233873, K243308, K243469, K260390
Cited as predicate by: K093983, K100111, K102597, K112926, K123562, K123918, K130009, K130061, K131657, K131764, K131834, K133541, K140607, K141680, K150561, K152000, K153374, K153716, K160553, K162507, K162674, K163383, K180310, K190391, K190430, K191793, K200701, K210205, K212601, K213108, K222282, K231292, K232394, K233665, K240318, K242399, K242973, K243308, K250933, K252191, K254093, K261351
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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