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.
12 linked reportsInjury 9Malfunction 3
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.94 |
| 2019-02 | 4 | 1.56 |
| 2019-03 | 0 | 1.88 |
| 2019-04 | 0 | 2.36 |
| 2019-05 | 0 | 1.69 |
| 2019-06 | 0 | 1.64 |
| 2019-07 | 0 | 1.68 |
| 2019-08 | 0 | 1.54 |
| 2019-09 | 0 | 1.66 |
| 2019-10 | 0 | 1.53 |
| 2019-11 | 0 | 1.8 |
| 2019-12 | 0 | 2 |
| 2020-01 | 0 | 2.19 |
| 2020-02 | 0 | 1.28 |
| 2020-03 | 1 | 1.64 |
| 2020-04 | 0 | 1.95 |
| 2020-05 | 0 | 1.79 |
| 2020-06 | 0 | 1.92 |
| 2020-07 | 0 | 1.93 |
| 2020-08 | 0 | 2.34 |
| 2020-09 | 0 | 2.75 |
| 2020-10 | 1 | 1.95 |
| 2020-11 | 0 | 2.34 |
| 2020-12 | 0 | 2.26 |
| 2021-01 | 0 | 1.79 |
| 2021-02 | 0 | 1.94 |
| 2021-03 | 0 | 2.13 |
| 2021-04 | 0 | 2.85 |
| 2021-05 | 0 | 2.64 |
| 2021-06 | 0 | 2.05 |
| 2021-07 | 0 | 2.28 |
| 2021-08 | 0 | 1.87 |
| 2021-09 | 0 | 2.04 |
| 2021-10 | 1 | 2.02 |
| 2021-11 | 0 | 2.05 |
| 2021-12 | 0 | 2.21 |
| 2022-01 | 0 | 2.88 |
| 2022-02 | 0 | 2 |
| 2022-03 | 0 | 1.65 |
| 2022-04 | 1 | 2.04 |
| 2022-05 | 0 | 1.96 |
| 2022-06 | 0 | 2.35 |
| 2022-07 | 0 | 2.26 |
| 2022-08 | 1 | 2.01 |
| 2022-09 | 0 | 2.39 |
| 2022-10 | 0 | 3 |
| 2022-11 | 0 | 2.93 |
| 2022-12 | 2 | 2.83 |
| 2023-01 | 0 | 2.51 |
| 2023-02 | 0 | 2.57 |
| 2023-03 | 0 | 2.98 |
| 2023-04 | 0 | 3.11 |
| 2023-05 | 0 | 4.19 |
| 2023-06 | 0 | 2.96 |
| 2023-07 | 0 | 2.23 |
| 2023-08 | 0 | 2.22 |
| 2023-09 | 0 | 2.08 |
| 2023-10 | 0 | 2.45 |
| 2023-11 | 0 | 2.03 |
| 2023-12 | 0 | 2.42 |
| 2024-01 | 0 | 2.06 |
| 2024-02 | 0 | 1.72 |
| 2024-03 | 1 | 1.82 |
| 2024-04 | 0 | 2.09 |
| 2024-05 | 0 | 1.95 |
| 2024-06 | 0 | 2.35 |
| 2024-07 | 0 | 2.23 |
| 2024-08 | 0 | 2.28 |
| 2024-09 | 0 | 1.66 |
| 2024-10 | 0 | 2.32 |
| 2024-11 | 0 | 1.61 |
| 2024-12 | 0 | 2.88 |
| 2025-01 | 0 | 1.62 |
| 2025-02 | 0 | 1.76 |
| 2025-03 | 0 | 2.68 |
| 2025-04 | 0 | 1.82 |
| 2025-05 | 0 | 2.08 |
| 2025-06 | 0 | 1.73 |
| 2025-07 | 0 | 2.09 |
| 2025-08 | 0 | 2.1 |
| 2025-09 | 0 | 1.75 |
| 2025-10 | 0 | 2.08 |
| 2025-11 | 0 | 1.92 |
| 2025-12 | 0 | 2.46 |
| 2026-01 | 0 | 1.7 |
| 2026-02 | 0 | 2 |
| 2026-03 | 0 | 3.1 |
| 2026-04 | 0 | 2.2 |
| 2026-05 | 0 | 2.03 |
| 2026-06 | 0 | 1.84 |
Failure-mode summaryAI-generated
12 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2020-07-21 | Z-2816-2020 | Class II | Terminated | May have one or more dimensional features out of tolerance includes: thread pitch diameter depth, thread minor diameter depth, plate thickness and end length out of tolerance that can potentially result in a reduced locking strength of an LCP screwDistribution: US Nationwide distribution. | 191 units | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2024-03-04 | 8030965-2024-03142 | Malfunction | Available | exact di |
| 2022-12-20 | 8030965-2022-11307 | Injury | Available | exact di |
| 2022-08-01 | 2939274-2022-03052 | Injury | Available | exact di |
| 2022-04-19 | 2939274-2022-01388 | Injury | Available | exact di |
| 2021-10-13 | 2939274-2021-06042 | Injury | Available | exact di |
| 2020-10-15 | 2939274-2020-04684 | Injury | Available | exact di |
| 2020-03-18 | 2939274-2020-01330 | Malfunction | Available | exact di |
| 2019-02-26 | 2939274-2019-56686 | Malfunction | Available | exact di |
| 2019-02-22 | 2939274-2019-56599 | Injury | Available | exact di |
| 2019-02-22 | 2939274-2019-56613 | Injury | Available | exact di |
| 2019-02-08 | 2939274-2019-56376 | Injury | Available | exact di |
Showing the most recent 11 of 12 linked reports.
Regulatory clearances
Predicate lineage
K011335
Cited as predicate by: K102785, K113652, K122936, K133691, K142502, K143385, K143394, K152000, K152289, K160553, K162829, K171285, K180310, K181035, K181113, K181587, K181843, K190430, K193633, K201510, K203002, K233665, K242399, K243469, K254054
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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