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.
19 linked reportsInjury 11Malfunction 8
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.33 |
| 2019-02 | 0 | 1.53 |
| 2019-03 | 0 | 2.33 |
| 2019-04 | 0 | 2.14 |
| 2019-05 | 0 | 2.28 |
| 2019-06 | 0 | 2.4 |
| 2019-07 | 0 | 1.92 |
| 2019-08 | 0 | 2.5 |
| 2019-09 | 0 | 3.42 |
| 2019-10 | 0 | 2.26 |
| 2019-11 | 0 | 1.86 |
| 2019-12 | 0 | 2.2 |
| 2020-01 | 0 | 3.07 |
| 2020-02 | 0 | 2.29 |
| 2020-03 | 0 | 2.4 |
| 2020-04 | 0 | 1.75 |
| 2020-05 | 0 | 1.67 |
| 2020-06 | 0 | 2.95 |
| 2020-07 | 0 | 2.33 |
| 2020-08 | 0 | 2.7 |
| 2020-09 | 0 | 2.59 |
| 2020-10 | 1 | 2.84 |
| 2020-11 | 1 | 2.83 |
| 2020-12 | 1 | 2.62 |
| 2021-01 | 0 | 3.19 |
| 2021-02 | 0 | 2.67 |
| 2021-03 | 1 | 2.87 |
| 2021-04 | 0 | 3.2 |
| 2021-05 | 1 | 2.67 |
| 2021-06 | 2 | 2.46 |
| 2021-07 | 0 | 2.4 |
| 2021-08 | 0 | 2.05 |
| 2021-09 | 0 | 2.9 |
| 2021-10 | 0 | 2.62 |
| 2021-11 | 0 | 2.63 |
| 2021-12 | 1 | 2 |
| 2022-01 | 1 | 2.63 |
| 2022-02 | 0 | 1.65 |
| 2022-03 | 0 | 2.41 |
| 2022-04 | 1 | 2.59 |
| 2022-05 | 0 | 2.73 |
| 2022-06 | 0 | 1.89 |
| 2022-07 | 0 | 2.29 |
| 2022-08 | 1 | 2.4 |
| 2022-09 | 0 | 2.17 |
| 2022-10 | 0 | 2.47 |
| 2022-11 | 0 | 2.32 |
| 2022-12 | 1 | 3.59 |
| 2023-01 | 1 | 2.25 |
| 2023-02 | 0 | 3.1 |
| 2023-03 | 2 | 2.81 |
| 2023-04 | 0 | 2 |
| 2023-05 | 0 | 4.46 |
| 2023-06 | 0 | 3.52 |
| 2023-07 | 0 | 3.38 |
| 2023-08 | 1 | 2.3 |
| 2023-09 | 0 | 3.46 |
| 2023-10 | 0 | 2.64 |
| 2023-11 | 0 | 3.76 |
| 2023-12 | 0 | 3.56 |
| 2024-01 | 0 | 2.48 |
| 2024-02 | 0 | 2.73 |
| 2024-03 | 0 | 2.95 |
| 2024-04 | 0 | 2.32 |
| 2024-05 | 0 | 4.15 |
| 2024-06 | 0 | 5.53 |
| 2024-07 | 0 | 3.14 |
| 2024-08 | 0 | 2.3 |
| 2024-09 | 0 | 2.76 |
| 2024-10 | 0 | 2.61 |
| 2024-11 | 0 | 2.5 |
| 2024-12 | 0 | 2.7 |
| 2025-01 | 0 | 3.35 |
| 2025-02 | 0 | 3.62 |
| 2025-03 | 0 | 3.11 |
| 2025-04 | 0 | 3 |
| 2025-05 | 0 | 3 |
| 2025-06 | 0 | 2.44 |
| 2025-07 | 0 | 2.88 |
| 2025-08 | 2 | 2.84 |
| 2025-09 | 0 | 1.89 |
| 2025-10 | 0 | 3 |
| 2025-11 | 0 | 2.94 |
| 2025-12 | 0 | 3.71 |
| 2026-01 | 0 | 2.45 |
| 2026-02 | 0 | 3.21 |
| 2026-03 | 0 | 2.39 |
| 2026-04 | 0 | 2.57 |
| 2026-05 | 1 | 3.8 |
| 2026-06 | 0 | 2.86 |
Failure-mode summaryAI-generated
19 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-05-05 | 3006524618-2026-00229 | Malfunction | Available | exact di |
| 2025-08-26 | 3006524618-2025-00461 | Malfunction | Available | exact di |
| 2025-08-26 | 3006524618-2025-00463 | Malfunction | Available | exact di |
| 2023-08-29 | 3006524618-2023-00338 | Malfunction | Available | exact di |
| 2023-03-24 | 3006524618-2023-00100 | Injury | Available | exact di |
| 2023-03-03 | 3006524618-2023-00072 | Injury | Available | exact di |
| 2023-01-02 | 3006524618-2023-00006 | Injury | Available | exact di |
| 2022-12-27 | 3006524618-2022-00522 | Injury | Available | exact di |
| 2022-08-12 | 3006524618-2022-00345 | Injury | Available | exact di |
| 2022-04-18 | 3006524618-2022-00209 | Injury | Available | exact di |
| 2022-01-25 | 3006524618-2022-00029 | Injury | Available | exact di |
| 2021-12-20 | 3006524618-2021-01062 | Injury | Available | exact di |
| 2021-06-22 | 3006524618-2021-00721 | Malfunction | Available | exact di |
| 2021-06-09 | 3006524618-2021-00702 | Injury | Available | exact di |
| 2021-05-07 | 3006524618-2021-00586 | Malfunction | Available | exact di |
Showing 1–15 of 19
Regulatory clearances
None linked.
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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