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.
52 linked reportsMalfunction 37Injury 15
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-02 | 0 | 1 |
| 2019-04 | 0 | 1 |
| 2019-05 | 0 | 1 |
| 2019-06 | 0 | 1.33 |
| 2019-07 | 0 | 1 |
| 2019-08 | 0 | 1 |
| 2019-09 | 0 | 1.5 |
| 2019-10 | 0 | 1 |
| 2019-12 | 0 | 1.5 |
| 2020-01 | 0 | 1 |
| 2020-02 | 0 | 1 |
| 2020-03 | 1 | 1.4 |
| 2020-04 | 1 | 1.4 |
| 2020-05 | 0 | 1 |
| 2020-06 | 0 | 1 |
| 2020-07 | 0 | 4.5 |
| 2020-08 | 0 | 2 |
| 2020-09 | 3 | 3 |
| 2020-10 | 6 | 4.5 |
| 2020-11 | 1 | 1 |
| 2020-12 | 3 | 2 |
| 2021-01 | 0 | 3.14 |
| 2021-03 | 0 | 2.75 |
| 2021-04 | 0 | 1.33 |
| 2021-05 | 0 | 3.14 |
| 2021-06 | 6 | 3.67 |
| 2021-07 | 0 | 2 |
| 2021-08 | 3 | 3.25 |
| 2021-09 | 0 | 1.8 |
| 2021-10 | 0 | 4 |
| 2021-11 | 0 | 4.5 |
| 2021-12 | 0 | 3 |
| 2022-01 | 0 | 1 |
| 2022-02 | 0 | 2.5 |
| 2022-03 | 0 | 2.75 |
| 2022-04 | 0 | 1 |
| 2022-05 | 3 | 2.33 |
| 2022-06 | 3 | 2.5 |
| 2022-07 | 0 | 2.17 |
| 2022-08 | 0 | 2.29 |
| 2022-09 | 0 | 2.86 |
| 2022-10 | 0 | 3.25 |
| 2022-11 | 0 | 2.5 |
| 2022-12 | 0 | 3.4 |
| 2023-01 | 0 | 2 |
| 2023-02 | 3 | 2 |
| 2023-03 | 0 | 1.5 |
| 2023-05 | 0 | 2.5 |
| 2023-06 | 0 | 1 |
| 2023-07 | 3 | 1.5 |
| 2023-08 | 0 | 2.2 |
| 2023-09 | 0 | 2 |
| 2023-10 | 2 | 1.67 |
| 2023-11 | 0 | 1.67 |
| 2023-12 | 0 | 2.33 |
| 2024-01 | 0 | 1.33 |
| 2024-02 | 0 | 1.67 |
| 2024-03 | 0 | 3.25 |
| 2024-04 | 0 | 3 |
| 2024-05 | 2 | 2 |
| 2024-06 | 0 | 2.25 |
| 2024-08 | 0 | 1.6 |
| 2024-09 | 0 | 1.75 |
| 2024-10 | 0 | 2.33 |
| 2024-11 | 0 | 5.67 |
| 2024-12 | 0 | 8.67 |
| 2025-01 | 0 | 2.6 |
| 2025-02 | 4 | 7 |
| 2025-03 | 4 | 5.33 |
| 2025-04 | 0 | 4.25 |
| 2025-05 | 0 | 3.33 |
| 2025-06 | 0 | 5 |
| 2025-07 | 0 | 2 |
| 2025-08 | 0 | 1.83 |
| 2025-09 | 0 | 3.17 |
| 2025-10 | 0 | 2.44 |
| 2025-11 | 2 | 3.8 |
| 2025-12 | 0 | 4.33 |
| 2026-01 | 0 | 1.5 |
| 2026-02 | 2 | 3.8 |
| 2026-03 | 0 | 2.8 |
| 2026-04 | 0 | 4 |
| 2026-05 | 0 | 17 |
| 2026-06 | 0 | 2 |
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 |
|---|---|---|---|---|
| 2026-02-24 | 1219602-2026-00600 | Malfunction | Available | catalog number |
| 2025-11-05 | 1219602-2025-02761 | Malfunction | Available | catalog number |
| 2025-03-25 | 1219602-2025-00661 | Malfunction | Available | catalog number |
| 2025-03-06 | 1219602-2025-00502 | Malfunction | Available | catalog number |
| 2025-02-25 | 1219602-2025-00447 | Malfunction | Available | catalog number |
| 2025-02-18 | 1219602-2025-00397 | Malfunction | Available | catalog number |
| 2024-05-10 | 1219602-2024-00982 | Injury | Available | catalog number |
| 2023-10-16 | 1219602-2023-01983 | Malfunction | Available | catalog number |
| 2023-07-12 | 1219602-2023-01136 | Malfunction | Available | catalog number |
| 2023-02-27 | 1219602-2023-00263 | Malfunction | Available | catalog number |
| 2022-06-03 | 1219602-2022-00826 | Malfunction | Available | catalog number |
| 2022-05-17 | 1219602-2022-00738 | Injury | Available | catalog number |
| 2021-08-13 | 1219602-2021-01712 | Malfunction | Available | catalog number |
| 2021-06-24 | 1219602-2021-01413 | Malfunction | Available | catalog number |
| 2021-06-18 | 1219602-2021-01385 | Malfunction | Available | catalog number |
Showing the most recent 22 of 52 linked reports.
Showing 1–15 of 22
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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