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.
13 linked reportsInjury 11Malfunction 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.48 |
| 2019-02 | 0 | 1.46 |
| 2019-03 | 0 | 1.35 |
| 2019-04 | 0 | 2 |
| 2019-05 | 0 | 1.33 |
| 2019-06 | 0 | 1.62 |
| 2019-07 | 0 | 2.13 |
| 2019-08 | 0 | 1.62 |
| 2019-09 | 1 | 1.45 |
| 2019-10 | 0 | 1.25 |
| 2019-11 | 0 | 1.33 |
| 2019-12 | 0 | 1.35 |
| 2020-01 | 2 | 1.6 |
| 2020-02 | 0 | 2.41 |
| 2020-03 | 1 | 1.43 |
| 2020-04 | 0 | 1.5 |
| 2020-05 | 0 | 1 |
| 2020-06 | 1 | 1.96 |
| 2020-07 | 1 | 1.5 |
| 2020-08 | 0 | 2.08 |
| 2020-09 | 0 | 2.38 |
| 2020-10 | 0 | 2.43 |
| 2020-11 | 0 | 1.72 |
| 2020-12 | 0 | 2.23 |
| 2021-01 | 1 | 1.6 |
| 2021-02 | 0 | 2.68 |
| 2021-03 | 2 | 2.64 |
| 2021-04 | 1 | 2.51 |
| 2021-05 | 0 | 2.82 |
| 2021-06 | 1 | 1.95 |
| 2021-07 | 0 | 1.71 |
| 2021-08 | 1 | 1.62 |
| 2021-09 | 0 | 1.76 |
| 2021-10 | 0 | 1.52 |
| 2021-11 | 0 | 2.83 |
| 2021-12 | 0 | 1.63 |
| 2022-01 | 0 | 2 |
| 2022-02 | 0 | 2.71 |
| 2022-03 | 0 | 2.12 |
| 2022-04 | 0 | 2.33 |
| 2022-05 | 0 | 4.67 |
| 2022-06 | 0 | 2.31 |
| 2022-07 | 0 | 2.1 |
| 2022-08 | 0 | 2.08 |
| 2022-09 | 0 | 2.52 |
| 2022-10 | 0 | 3 |
| 2022-11 | 0 | 3.44 |
| 2022-12 | 0 | 2.44 |
| 2023-01 | 0 | 2.92 |
| 2023-02 | 0 | 2.15 |
| 2023-03 | 0 | 2.15 |
| 2023-04 | 0 | 2.31 |
| 2023-05 | 0 | 3.16 |
| 2023-06 | 0 | 2.14 |
| 2023-07 | 0 | 2.17 |
| 2023-08 | 0 | 1.46 |
| 2023-09 | 1 | 2.25 |
| 2023-10 | 0 | 1.2 |
| 2023-11 | 0 | 1.25 |
| 2023-12 | 0 | 1.33 |
| 2024-01 | 0 | 1.2 |
| 2024-02 | 0 | 2.17 |
| 2024-03 | 0 | 1.35 |
| 2024-04 | 0 | 1.83 |
| 2024-05 | 0 | 1.43 |
| 2024-06 | 0 | 1.45 |
| 2024-07 | 0 | 1.1 |
| 2024-08 | 0 | 1.64 |
| 2024-09 | 0 | 1.25 |
| 2024-10 | 0 | 2 |
| 2024-11 | 0 | 1.67 |
| 2024-12 | 0 | 4.25 |
| 2025-01 | 0 | 1.29 |
| 2025-02 | 0 | 1.62 |
| 2025-03 | 0 | 1.25 |
| 2025-04 | 0 | 2 |
| 2025-05 | 0 | 1.44 |
| 2025-06 | 0 | 1.26 |
| 2025-07 | 0 | 1.73 |
| 2025-08 | 0 | 1.24 |
| 2025-09 | 0 | 1.54 |
| 2025-10 | 0 | 2.56 |
| 2025-11 | 0 | 1.86 |
| 2025-12 | 0 | 1.8 |
| 2026-01 | 0 | 1.57 |
| 2026-02 | 0 | 1.22 |
| 2026-03 | 0 | 1.25 |
| 2026-04 | 0 | 1.5 |
| 2026-05 | 0 | 3.33 |
| 2026-06 | 0 | 1.4 |
Failure-mode summaryAI-generated
13 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2023-09-25 | 8030965-2023-12063 | Malfunction | Available | exact di |
| 2021-08-13 | 2939274-2021-04669 | Injury | Available | exact di |
| 2021-06-28 | 2939274-2021-03286 | Injury | Available | exact di |
| 2021-04-26 | 2939274-2021-02080 | Injury | Available | exact di |
| 2021-03-29 | 2939274-2021-01579 | Injury | Available | exact di |
| 2021-03-25 | 2939274-2021-01531 | Injury | Available | exact di |
| 2021-01-26 | 2939274-2021-00492 | Injury | Available | exact di |
| 2020-07-09 | 8030965-2020-04732 | Injury | Available | exact di |
| 2020-06-24 | 2939274-2020-02964 | Injury | Available | exact di |
| 2020-03-30 | 2939274-2020-01580 | Injury | Available | exact di |
| 2020-01-30 | 2939274-2020-00556 | Malfunction | Available | exact di |
| 2020-01-29 | 2939274-2020-00444 | Injury | Available | exact di |
| 2019-09-30 | 2939274-2019-61045 | Injury | Available | exact di |
Regulatory clearances
Predicate lineage
- K172872
Cited as predicate by: K182154
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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