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 reportMalfunction 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-02 | 0 | 2 |
| 2019-03 | 0 | 1 |
| 2019-04 | 0 | 1 |
| 2019-05 | 0 | 1.67 |
| 2019-06 | 0 | 3 |
| 2019-07 | 0 | 1 |
| 2019-08 | 0 | 3 |
| 2019-09 | 0 | 1 |
| 2019-10 | 0 | 1.25 |
| 2019-11 | 0 | 1 |
| 2019-12 | 0 | 1 |
| 2020-01 | 0 | 1 |
| 2020-02 | 0 | 1 |
| 2020-07 | 0 | 3 |
| 2020-08 | 0 | 1.25 |
| 2020-09 | 0 | 1 |
| 2020-10 | 0 | 2 |
| 2021-01 | 0 | 1 |
| 2021-03 | 0 | 2.67 |
| 2021-04 | 0 | 1 |
| 2021-05 | 0 | 1.75 |
| 2021-06 | 0 | 1 |
| 2021-07 | 0 | 1 |
| 2021-10 | 0 | 1 |
| 2021-11 | 0 | 2.33 |
| 2021-12 | 0 | 1.5 |
| 2022-01 | 0 | 2 |
| 2022-02 | 0 | 1 |
| 2022-03 | 0 | 1 |
| 2022-04 | 0 | 1.8 |
| 2022-06 | 0 | 1.5 |
| 2022-07 | 0 | 3.33 |
| 2022-08 | 0 | 1.17 |
| 2022-09 | 0 | 1.75 |
| 2022-10 | 0 | 1.75 |
| 2022-11 | 1 | 2.86 |
| 2022-12 | 0 | 6 |
| 2023-01 | 0 | 2 |
| 2023-02 | 0 | 2 |
| 2023-03 | 0 | 1.67 |
| 2023-05 | 0 | 1 |
| 2023-06 | 0 | 1 |
| 2023-07 | 0 | 1 |
| 2023-08 | 0 | 1 |
| 2023-09 | 0 | 1 |
| 2023-10 | 0 | 1 |
| 2023-11 | 0 | 1 |
| 2023-12 | 0 | 1 |
| 2024-02 | 0 | 1 |
| 2024-03 | 0 | 1.33 |
| 2024-04 | 0 | 1.25 |
| 2024-05 | 0 | 1.5 |
| 2024-06 | 0 | 2.25 |
| 2024-07 | 0 | 1.6 |
| 2024-08 | 0 | 1 |
| 2024-09 | 0 | 1.5 |
| 2024-10 | 0 | 3.5 |
| 2024-11 | 0 | 1 |
| 2024-12 | 0 | 1 |
| 2025-02 | 0 | 1 |
| 2025-06 | 0 | 1.14 |
| 2025-08 | 0 | 1 |
| 2025-09 | 0 | 1 |
| 2025-10 | 0 | 2.2 |
| 2025-11 | 0 | 1.33 |
| 2025-12 | 0 | 1.38 |
| 2026-01 | 0 | 1 |
| 2026-02 | 0 | 1 |
| 2026-03 | 0 | 1 |
| 2026-04 | 0 | 2 |
| 2026-05 | 0 | 1 |
| 2026-06 | 0 | 1 |
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 |
|---|---|---|---|---|
| 2022-11-30 | 8030965-2022-10403 | Malfunction | Available | model number |
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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