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.
142 linked reportsMalfunction 104Injury 38
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.72 |
| 2019-02 | 2 | 2.45 |
| 2019-03 | 0 | 2.79 |
| 2019-04 | 2 | 2.65 |
| 2019-05 | 0 | 2.07 |
| 2019-06 | 0 | 1.85 |
| 2019-07 | 0 | 1.73 |
| 2019-08 | 1 | 2.19 |
| 2019-09 | 1 | 2.2 |
| 2019-10 | 2 | 2.5 |
| 2019-11 | 1 | 2.2 |
| 2019-12 | 0 | 2.55 |
| 2020-01 | 0 | 3.08 |
| 2020-02 | 0 | 2.52 |
| 2020-03 | 4 | 3.17 |
| 2020-04 | 0 | 2.37 |
| 2020-05 | 0 | 2.26 |
| 2020-06 | 0 | 2.13 |
| 2020-07 | 0 | 2.62 |
| 2020-08 | 3 | 2.21 |
| 2020-09 | 3 | 2.8 |
| 2020-10 | 14 | 2.76 |
| 2020-11 | 0 | 2.4 |
| 2020-12 | 3 | 2.47 |
| 2021-01 | 3 | 2.52 |
| 2021-02 | 1 | 2.24 |
| 2021-03 | 0 | 2.2 |
| 2021-04 | 1 | 2.17 |
| 2021-05 | 7 | 2.19 |
| 2021-06 | 3 | 2.49 |
| 2021-07 | 6 | 2.58 |
| 2021-08 | 3 | 2.56 |
| 2021-09 | 3 | 2.75 |
| 2021-10 | 0 | 2.46 |
| 2021-11 | 3 | 2.22 |
| 2021-12 | 3 | 2.46 |
| 2022-01 | 3 | 2.31 |
| 2022-02 | 9 | 2.33 |
| 2022-03 | 3 | 2.38 |
| 2022-04 | 9 | 2.3 |
| 2022-05 | 3 | 2.46 |
| 2022-06 | 3 | 2.32 |
| 2022-07 | 3 | 2.32 |
| 2022-08 | 3 | 2.33 |
| 2022-09 | 3 | 2.44 |
| 2022-10 | 3 | 2.4 |
| 2022-11 | 0 | 2.48 |
| 2022-12 | 0 | 2.48 |
| 2023-01 | 0 | 2.63 |
| 2023-02 | 0 | 2.34 |
| 2023-03 | 0 | 2.47 |
| 2023-04 | 0 | 2.44 |
| 2023-05 | 0 | 2.35 |
| 2023-06 | 0 | 2.45 |
| 2023-07 | 3 | 2.31 |
| 2023-08 | 2 | 2.02 |
| 2023-09 | 2 | 2.04 |
| 2023-10 | 0 | 1.8 |
| 2023-11 | 0 | 1.78 |
| 2023-12 | 2 | 1.89 |
| 2024-01 | 2 | 1.84 |
| 2024-02 | 2 | 2.21 |
| 2024-03 | 2 | 2.01 |
| 2024-04 | 0 | 1.91 |
| 2024-05 | 2 | 2.24 |
| 2024-06 | 0 | 2 |
| 2024-07 | 6 | 1.82 |
| 2024-08 | 0 | 2.05 |
| 2024-09 | 0 | 2.05 |
| 2024-10 | 0 | 1.87 |
| 2024-11 | 0 | 1.99 |
| 2024-12 | 0 | 1.71 |
| 2025-01 | 2 | 2.18 |
| 2025-02 | 0 | 1.66 |
| 2025-03 | 2 | 1.85 |
| 2025-04 | 0 | 1.95 |
| 2025-05 | 0 | 1.94 |
| 2025-06 | 0 | 1.97 |
| 2025-07 | 0 | 1.92 |
| 2025-08 | 0 | 1.94 |
| 2025-09 | 0 | 1.75 |
| 2025-10 | 0 | 1.84 |
| 2025-11 | 0 | 1.9 |
| 2025-12 | 0 | 1.99 |
| 2026-01 | 0 | 2.04 |
| 2026-02 | 0 | 1.83 |
| 2026-03 | 0 | 1.98 |
| 2026-04 | 0 | 2.12 |
| 2026-05 | 2 | 1.92 |
| 2026-06 | 2 | 1.88 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-20 | 1020279-2026-00845 | Malfunction | Available | catalog number |
| 2026-05-01 | 1020279-2026-00594 | Malfunction | Available | catalog number |
| 2025-03-03 | 1020279-2025-00386 | Malfunction | Available | catalog number |
| 2025-01-02 | 1020279-2025-00008 | Malfunction | Available | catalog number |
| 2024-07-19 | 1020279-2024-01407 | Injury | Available | catalog number |
| 2024-07-15 | 1020279-2024-01368 | Malfunction | Available | catalog number |
| 2024-07-11 | 1020279-2024-01343 | Malfunction | Available | catalog number |
| 2024-05-15 | 1020279-2024-00941 | Malfunction | Available | catalog number |
| 2024-03-25 | 1020279-2024-00606 | Injury | Available | catalog number |
| 2024-02-26 | 1020279-2024-00435 | Malfunction | Available | catalog number |
| 2024-01-07 | 1020279-2024-00034 | Malfunction | Available | catalog number |
| 2023-12-27 | 1020279-2023-02605 | Malfunction | Available | catalog number |
| 2023-09-18 | 1020279-2023-01778 | Malfunction | Available | catalog number |
| 2023-08-04 | 1020279-2023-01560 | Malfunction | Available | catalog number |
| 2023-07-11 | 1020279-2023-01435 | Malfunction | Available | catalog number |
Showing the most recent 60 of 142 linked reports.
Showing 1–15 of 60
Regulatory clearances
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-01-27 | NAI | No action indicated | Integrity Orthopaedics Inc | 0 |
| 2023-05-03 | NAI | No action indicated | CARTIHEAL, LTD | 0 |
| 2021-12-09 | VAI | Voluntary action indicated | Smith & Nephew, Inc. | 1 |
| 2021-12-09 | VAI | Voluntary action indicated | Smith & Nephew, Inc. | 1 |
| 2021-10-26 | NAI | No action indicated | Smith & Nephew Inc. | 0 |
| 2021-10-26 | NAI | No action indicated | Smith & Nephew Inc. | 0 |
| 2020-02-06 | VAI | Voluntary action indicated | Blue Belt Technologies, Inc | 6 |
| 2019-10-25 | NAI | No action indicated | Tusker Medical, Inc. | 0 |
| 2019-10-08 | VAI | Voluntary action indicated | Tusker Medical, Inc. | 3 |
| 2018-03-30 | NAI | No action indicated | Ascension Orthopedics, Inc | 0 |
| 2018-02-02 | NAI | No action indicated | Smith & Nephew, Inc. | 0 |
| 2018-02-02 | NAI | No action indicated | Smith & Nephew, Inc. | 0 |
| 2018-01-30 | NAI | No action indicated | Smith & Nephew | 0 |
| 2017-08-21 | NAI | No action indicated | Smith & Nephew, Inc. Advanced Surgical Devices Division | 0 |
| 2017-08-02 | VAI | Voluntary action indicated | Smith & Nephew, Inc. | 3 |
| 2017-08-02 | VAI | Voluntary action indicated | Smith & Nephew, Inc. | 3 |
| 2017-07-24 | NAI | No action indicated | Smith & Nephew, Inc. | 0 |
| 2017-07-24 | NAI | No action indicated | Smith & Nephew, Inc. | 0 |
| 2017-05-25 | NAI | No action indicated | Smith & Nephew, Inc. | 0 |
| 2017-05-25 | NAI | No action indicated | Smith & Nephew, Inc. | 0 |
| 2015-04-30 | WL | Warning Letter | Smith & Nephew Inc. | — |
| 2015-04-30 | WL | Warning Letter | Smith & Nephew Inc. | — |
| 2014-06-11 | WL | Warning Letter | Smith & Nephew, Inc. | — |
| 2010-09-16 | WL | Warning Letter | Ascension Orthopedics, Inc | — |
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