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.
84 linked reportsInjury 70Malfunction 14
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 2 | 2.15 |
| 2019-02 | 8 | 2.14 |
| 2019-03 | 0 | 1.93 |
| 2019-04 | 2 | 2.11 |
| 2019-05 | 0 | 2.3 |
| 2019-06 | 0 | 2.57 |
| 2019-07 | 0 | 1.67 |
| 2019-08 | 0 | 3 |
| 2019-09 | 0 | 1.75 |
| 2019-10 | 0 | 1.92 |
| 2019-11 | 0 | 2.44 |
| 2019-12 | 2 | 1.59 |
| 2020-01 | 2 | 2.43 |
| 2020-02 | 2 | 2.23 |
| 2020-03 | 4 | 2.38 |
| 2020-04 | 2 | 1.6 |
| 2020-05 | 0 | 2.71 |
| 2020-06 | 0 | 1.75 |
| 2020-07 | 0 | 2.06 |
| 2020-08 | 0 | 2.08 |
| 2020-09 | 0 | 2.52 |
| 2020-10 | 2 | 2.75 |
| 2020-11 | 0 | 2.36 |
| 2020-12 | 0 | 1.97 |
| 2021-01 | 0 | 2.4 |
| 2021-02 | 0 | 1.89 |
| 2021-03 | 3 | 2.61 |
| 2021-04 | 4 | 2.4 |
| 2021-05 | 0 | 2 |
| 2021-06 | 9 | 2.4 |
| 2021-07 | 0 | 2.27 |
| 2021-08 | 6 | 2.02 |
| 2021-09 | 2 | 1.95 |
| 2021-10 | 2 | 2.57 |
| 2021-11 | 0 | 2.35 |
| 2021-12 | 2 | 2.54 |
| 2022-01 | 6 | 2.18 |
| 2022-02 | 0 | 2.12 |
| 2022-03 | 0 | 1.9 |
| 2022-04 | 0 | 2.06 |
| 2022-05 | 0 | 1.9 |
| 2022-06 | 0 | 2.09 |
| 2022-07 | 6 | 4.92 |
| 2022-08 | 0 | 1.8 |
| 2022-09 | 0 | 2.66 |
| 2022-10 | 0 | 1.61 |
| 2022-11 | 2 | 1.8 |
| 2022-12 | 8 | 2.27 |
| 2023-01 | 0 | 1.97 |
| 2023-02 | 0 | 1.85 |
| 2023-03 | 0 | 1.64 |
| 2023-04 | 2 | 1.92 |
| 2023-05 | 0 | 1.56 |
| 2023-06 | 0 | 1.75 |
| 2023-07 | 2 | 2.05 |
| 2023-08 | 0 | 2.22 |
| 2023-09 | 0 | 2.61 |
| 2023-10 | 0 | 2.69 |
| 2023-11 | 0 | 2.46 |
| 2023-12 | 0 | 1.74 |
| 2024-01 | 0 | 2.44 |
| 2024-02 | 0 | 2.29 |
| 2024-03 | 2 | 3.6 |
| 2024-04 | 0 | 1.7 |
| 2024-05 | 0 | 3.68 |
| 2024-06 | 0 | 3.14 |
| 2024-07 | 0 | 1.96 |
| 2024-08 | 0 | 2 |
| 2024-09 | 0 | 3.67 |
| 2024-10 | 0 | 2.27 |
| 2024-11 | 0 | 2.18 |
| 2024-12 | 0 | 2.1 |
| 2025-01 | 2 | 2.32 |
| 2025-02 | 0 | 2.66 |
| 2025-03 | 0 | 2.4 |
| 2025-04 | 0 | 2.39 |
| 2025-05 | 0 | 2.64 |
| 2025-06 | 0 | 2.25 |
| 2025-07 | 0 | 1.9 |
| 2025-08 | 0 | 2.02 |
| 2025-09 | 0 | 1.81 |
| 2025-10 | 0 | 1.81 |
| 2025-11 | 0 | 2.03 |
| 2025-12 | 0 | 2.7 |
| 2026-01 | 0 | 2.28 |
| 2026-02 | 0 | 2.42 |
| 2026-03 | 0 | 2.37 |
| 2026-04 | 0 | 1.94 |
| 2026-05 | 0 | 2.28 |
| 2026-06 | 0 | 3.87 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2022-07-15 | Z-1638-2022 | Class II | Open, Classified | Potential for the incorrect screw to be included in the package.Distribution: GA, TX | 6 units | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-01-13 | 9610612-2025-00006 | Injury | Available | catalog number |
| 2024-03-19 | 9610612-2024-00053 | Injury | Available | catalog number |
| 2023-07-11 | 9610612-2023-00176 | Injury | Available | catalog number |
| 2023-04-07 | 9610612-2023-00072 | Injury | Available | catalog number |
| 2022-12-29 | 9610612-2022-00381 | Injury | Available | catalog number |
| 2022-12-15 | 9610612-2022-00370 | Injury | Available | catalog number |
| 2022-12-15 | 9610612-2022-00371 | Injury | Available | catalog number |
| 2022-12-07 | 9610612-2022-00367 | Injury | Available | catalog number |
| 2022-11-16 | 9610612-2022-00343 | Injury | Available | catalog number |
| 2022-07-12 | 9610612-2022-00192 | Malfunction | Available | catalog number |
| 2022-07-05 | 9610612-2022-00183 | Injury | Available | catalog number |
| 2022-07-05 | 9610612-2022-00186 | Injury | Available | catalog number |
| 2022-01-11 | 9610612-2021-00810 | Injury | Available | catalog number |
| 2022-01-11 | 9610612-2021-00811 | Injury | Available | catalog number |
| 2022-01-11 | 9610612-2021-00812 | Injury | Available | catalog number |
Showing the most recent 40 of 84 linked reports.
Showing 1–15 of 40
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-07-11 | NAI | No action indicated | Aesculap Inc | 0 |
| 2025-07-11 | NAI | No action indicated | Aesculap Inc | 0 |
| 2022-07-21 | NAI | No action indicated | Aesculap AG | 0 |
| 2022-07-21 | NAI | No action indicated | Aesculap AG | 0 |
| 2021-08-11 | VAI | Voluntary action indicated | Aesculap Inc | 3 |
| 2021-08-11 | VAI | Voluntary action indicated | Aesculap Inc | 3 |
| 2018-06-13 | VAI | Voluntary action indicated | Aesculap Inc | 0 |
| 2018-06-13 | VAI | Voluntary action indicated | Aesculap Inc | 0 |
| 2016-09-22 | NAI | No action indicated | Aesculap AG | 0 |
| 2016-09-22 | NAI | No action indicated | Aesculap AG | 0 |
| 2016-09-14 | VAI | Voluntary action indicated | Aesculap Inc | 0 |
| 2016-09-14 | VAI | Voluntary action indicated | Aesculap Inc | 0 |
| 2016-07-13 | NAI | No action indicated | Aesculap Inc | 0 |
| 2016-07-13 | NAI | No action indicated | Aesculap Inc | 0 |
| 2015-07-16 | NAI | No action indicated | Aesculap AG | 1 |
| 2015-07-16 | NAI | No action indicated | Aesculap AG | 1 |
| 2015-05-05 | NAI | No action indicated | Aesculap Inc | 0 |
| 2015-05-05 | NAI | No action indicated | Aesculap Inc | 0 |
| 2014-10-23 | NAI | No action indicated | Aesculap Inc | 0 |
| 2014-10-23 | NAI | No action indicated | Aesculap Inc | 0 |
| 2011-09-26 | WL | Warning Letter | Aesculap AG | — |
| 2011-09-26 | WL | Warning Letter | Aesculap AG | — |
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