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.
105 linked reportsMalfunction 105
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 3 | 6.86 |
| 2019-02 | 1 | 4.35 |
| 2019-03 | 1 | 4.42 |
| 2019-04 | 5 | 6.12 |
| 2019-05 | 1 | 4.8 |
| 2019-06 | 4 | 5.04 |
| 2019-07 | 3 | 5.86 |
| 2019-08 | 1 | 6.1 |
| 2019-09 | 0 | 4.99 |
| 2019-10 | 2 | 5.85 |
| 2019-11 | 1 | 5.62 |
| 2019-12 | 2 | 5.41 |
| 2020-01 | 0 | 4.81 |
| 2020-02 | 2 | 5.57 |
| 2020-03 | 1 | 5.68 |
| 2020-04 | 2 | 3.57 |
| 2020-05 | 1 | 3.76 |
| 2020-06 | 2 | 5.14 |
| 2020-07 | 1 | 6.56 |
| 2020-08 | 3 | 4.64 |
| 2020-09 | 2 | 5.86 |
| 2020-10 | 0 | 5.55 |
| 2020-11 | 1 | 5.14 |
| 2020-12 | 1 | 5.31 |
| 2021-01 | 0 | 5.17 |
| 2021-02 | 0 | 4.89 |
| 2021-03 | 1 | 5.7 |
| 2021-04 | 4 | 5.26 |
| 2021-05 | 3 | 5.14 |
| 2021-06 | 0 | 5.83 |
| 2021-07 | 0 | 4.89 |
| 2021-08 | 1 | 4.3 |
| 2021-09 | 1 | 4.77 |
| 2021-10 | 0 | 6.17 |
| 2021-11 | 2 | 5.57 |
| 2021-12 | 0 | 5.56 |
| 2022-01 | 0 | 5.04 |
| 2022-02 | 2 | 5.15 |
| 2022-03 | 2 | 5.75 |
| 2022-04 | 2 | 4.98 |
| 2022-05 | 0 | 5.78 |
| 2022-06 | 0 | 6.3 |
| 2022-07 | 3 | 4.36 |
| 2022-08 | 0 | 4.59 |
| 2022-09 | 0 | 5 |
| 2022-10 | 2 | 4.76 |
| 2022-11 | 2 | 4.61 |
| 2022-12 | 0 | 4.04 |
| 2023-01 | 2 | 5.52 |
| 2023-02 | 0 | 4.59 |
| 2023-03 | 1 | 4.87 |
| 2023-04 | 1 | 4.78 |
| 2023-05 | 0 | 5.14 |
| 2023-06 | 1 | 4.78 |
| 2023-07 | 0 | 4.82 |
| 2023-08 | 0 | 4.44 |
| 2023-09 | 0 | 5.23 |
| 2023-10 | 3 | 5.1 |
| 2023-11 | 0 | 4.38 |
| 2023-12 | 0 | 4.79 |
| 2024-01 | 0 | 5.54 |
| 2024-02 | 0 | 5.46 |
| 2024-03 | 1 | 6.16 |
| 2024-04 | 0 | 6.04 |
| 2024-05 | 0 | 6.28 |
| 2024-06 | 0 | 5.39 |
| 2024-07 | 0 | 5.05 |
| 2024-08 | 0 | 5.01 |
| 2024-09 | 0 | 5.19 |
| 2024-10 | 0 | 5.7 |
| 2024-11 | 1 | 5.29 |
| 2024-12 | 1 | 4.06 |
| 2025-01 | 0 | 5.17 |
| 2025-02 | 0 | 4.46 |
| 2025-03 | 2 | 6.28 |
| 2025-04 | 3 | 4.39 |
| 2025-05 | 0 | 5.16 |
| 2025-06 | 1 | 5.08 |
| 2025-07 | 0 | 5.2 |
| 2025-08 | 1 | 5.45 |
| 2025-09 | 1 | 4.85 |
| 2025-10 | 0 | 5.14 |
| 2025-11 | 0 | 5.55 |
| 2025-12 | 11 | 5.81 |
| 2026-01 | 0 | 5.63 |
| 2026-02 | 0 | 5.98 |
| 2026-03 | 8 | 6.2 |
| 2026-04 | 0 | 5.43 |
| 2026-05 | 0 | 6.19 |
| 2026-06 | 2 | 5.56 |
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 |
|---|---|---|---|---|
| 2026-06-11 | 1320894-2026-00141 | Malfunction | Available | catalog number |
| 2026-03-12 | 1320894-2026-00053 | Malfunction | Available | catalog number |
| 2026-03-12 | 1320894-2026-00060 | Malfunction | Available | catalog number |
| 2026-03-12 | 1320894-2026-00057 | Malfunction | Available | catalog number |
| 2026-03-12 | 1320894-2026-00058 | Malfunction | Available | catalog number |
| 2025-12-17 | 1320894-2025-00287 | Malfunction | Available | catalog number |
| 2025-12-15 | 1320894-2025-00280 | Malfunction | Available | catalog number |
| 2025-12-11 | 1320894-2025-00274 | Malfunction | Available | catalog number |
| 2025-12-11 | 1320894-2025-00275 | Malfunction | Available | catalog number |
| 2025-12-11 | 1320894-2025-00273 | Malfunction | Available | exact di |
| 2025-12-10 | 1320894-2025-00271 | Malfunction | Available | catalog number |
| 2025-09-12 | 1320894-2025-00220 | Malfunction | Available | exact di |
| 2025-08-01 | 1320894-2025-00184 | Malfunction | Available | exact di |
| 2025-06-05 | 1320894-2025-00148 | Malfunction | Available | exact di |
| 2025-04-25 | 1320894-2025-00119 | Malfunction | Available | exact di |
Showing the most recent 89 of 105 linked reports.
Showing 1–15 of 89
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2026-05-13 | NAI | No action indicated | Biorez, Inc | 0 |
| 2026-04-06 | VAI | Voluntary action indicated | ConMed Corporation | 6 |
| 2026-04-06 | VAI | Voluntary action indicated | ConMed Corporation | 6 |
| 2023-12-14 | NAI | No action indicated | Linvatec Corp. | 0 |
| 2023-08-04 | VAI | Voluntary action indicated | Biorez, Inc | 1 |
| 2022-11-10 | NAI | No action indicated | ConMed Corporation | 0 |
| 2022-11-10 | NAI | No action indicated | ConMed Corporation | 0 |
| 2022-07-13 | NAI | No action indicated | ConMed Corporation | 0 |
| 2022-07-13 | NAI | No action indicated | ConMed Corporation | 0 |
| 2020-09-22 | VAI | Voluntary action indicated | ConMed Corporation | 0 |
| 2020-09-22 | VAI | Voluntary action indicated | ConMed Corporation | 0 |
| 2019-10-17 | NAI | No action indicated | ConMed Corporation | 0 |
| 2019-10-17 | NAI | No action indicated | ConMed Corporation | 0 |
| 2017-02-03 | VAI | Voluntary action indicated | ConMed Corporation | 2 |
| 2017-02-03 | VAI | Voluntary action indicated | ConMed Corporation | 2 |
| 2017-01-23 | NAI | No action indicated | Conmed | 0 |
| 2016-02-03 | VAI | Voluntary action indicated | ConMed Corporation | 5 |
| 2016-02-03 | VAI | Voluntary action indicated | ConMed Corporation | 5 |
| 2014-11-18 | NAI | No action indicated | ConMed Corporation | 0 |
| 2014-11-18 | NAI | No action indicated | ConMed Corporation | 0 |
| 2014-01-29 | WL | Warning Letter | ConMed Corporation | — |
| 2014-01-29 | WL | Warning Letter | ConMed Corporation | — |
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