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.
350 linked reportsMalfunction 325Injury 25
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 7 | 3.07 |
| 2019-02 | 9 | 3.8 |
| 2019-03 | 7 | 3.09 |
| 2019-04 | 3 | 1.86 |
| 2019-05 | 3 | 2.02 |
| 2019-06 | 2 | 1.57 |
| 2019-07 | 3 | 1.72 |
| 2019-08 | 4 | 4.08 |
| 2019-09 | 7 | 2.77 |
| 2019-10 | 14 | 4.26 |
| 2019-11 | 15 | 4.47 |
| 2019-12 | 8 | 4.76 |
| 2020-01 | 4 | 3.33 |
| 2020-02 | 4 | 2.1 |
| 2020-03 | 0 | 3.9 |
| 2020-04 | 0 | 2.54 |
| 2020-05 | 0 | 1.55 |
| 2020-06 | 0 | 1.69 |
| 2020-07 | 0 | 2.68 |
| 2020-08 | 1 | 2.92 |
| 2020-09 | 2 | 2.89 |
| 2020-10 | 3 | 4.06 |
| 2020-11 | 2 | 2.7 |
| 2020-12 | 6 | 2.89 |
| 2021-01 | 1 | 1.16 |
| 2021-02 | 0 | 2.22 |
| 2021-03 | 1 | 1.84 |
| 2021-04 | 2 | 1.97 |
| 2021-05 | 1 | 1.66 |
| 2021-06 | 2 | 2.28 |
| 2021-07 | 0 | 3.11 |
| 2021-08 | 1 | 2.31 |
| 2021-09 | 4 | 4 |
| 2021-10 | 0 | 2.62 |
| 2021-11 | 0 | 2 |
| 2021-12 | 2 | 1.59 |
| 2022-01 | 0 | 2.18 |
| 2022-02 | 0 | 1.95 |
| 2022-03 | 0 | 1.46 |
| 2022-04 | 0 | 2.44 |
| 2022-05 | 3 | 2.77 |
| 2022-06 | 0 | 2.17 |
| 2022-07 | 4 | 1.77 |
| 2022-08 | 3 | 2.15 |
| 2022-09 | 0 | 2.12 |
| 2022-10 | 5 | 2.46 |
| 2022-11 | 0 | 2.18 |
| 2022-12 | 4 | 2.03 |
| 2023-01 | 0 | 2.73 |
| 2023-02 | 5 | 2.11 |
| 2023-03 | 1 | 2.27 |
| 2023-04 | 1 | 1.65 |
| 2023-05 | 3 | 2.35 |
| 2023-06 | 0 | 2.05 |
| 2023-07 | 1 | 1.75 |
| 2023-08 | 6 | 2.89 |
| 2023-09 | 0 | 3.44 |
| 2023-10 | 6 | 6.93 |
| 2023-11 | 11 | 6 |
| 2023-12 | 4 | 7.44 |
| 2024-01 | 3 | 5.07 |
| 2024-02 | 8 | 6.33 |
| 2024-03 | 5 | 6.35 |
| 2024-04 | 12 | 8.98 |
| 2024-05 | 5 | 8.71 |
| 2024-06 | 7 | 6.63 |
| 2024-07 | 6 | 10.31 |
| 2024-08 | 5 | 12.34 |
| 2024-09 | 10 | 17.49 |
| 2024-10 | 12 | 14.17 |
| 2024-11 | 3 | 12.6 |
| 2024-12 | 8 | 9.08 |
| 2025-01 | 2 | 8.76 |
| 2025-02 | 9 | 14.62 |
| 2025-03 | 16 | 13.68 |
| 2025-04 | 4 | 10.84 |
| 2025-05 | 3 | 8.45 |
| 2025-06 | 9 | 9.62 |
| 2025-07 | 1 | 16.34 |
| 2025-08 | 4 | 9.21 |
| 2025-09 | 5 | 10.32 |
| 2025-10 | 2 | 15.2 |
| 2025-11 | 6 | 13.17 |
| 2025-12 | 8 | 12.27 |
| 2026-01 | 4 | 9.72 |
| 2026-02 | 3 | 9.3 |
| 2026-03 | 9 | 11.82 |
| 2026-04 | 1 | 11.74 |
| 2026-05 | 2 | 12.65 |
| 2026-06 | 3 | 13.23 |
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 |
|---|---|---|---|---|
| 2026-06-15 | 1045254-2026-00838 | Malfunction | Available | model number |
| 2026-06-04 | 1045254-2026-00786 | Malfunction | Available | exact di |
| 2026-05-19 | 1045254-2026-00700 | Malfunction | Available | model number |
| 2026-05-18 | 1045254-2026-00695 | Malfunction | Available | model number |
| 2026-04-09 | 1045254-2026-00493 | Malfunction | Available | model number |
| 2026-03-24 | 1045254-2026-00397 | Malfunction | Available | exact di |
| 2026-03-17 | 1045254-2026-00357 | Malfunction | Available | exact di |
| 2026-03-17 | 1045254-2026-00358 | Malfunction | Available | model number |
| 2026-03-16 | 1045254-2026-00347 | Malfunction | Available | exact di |
| 2026-03-12 | 1045254-2026-00334 | Malfunction | Available | exact di |
| 2026-02-15 | 1045254-2026-00213 | Malfunction | Available | exact di |
| 2026-02-03 | 1045254-2026-00142 | Injury | Available | model number |
| 2026-01-29 | 1045254-2026-00116 | Malfunction | Available | exact di |
| 2026-01-07 | 1045254-2026-00042 | Malfunction | Available | model number |
| 2026-01-02 | 1045254-2026-00005 | Malfunction | Available | model number |
Showing the most recent 200 of 350 linked reports.
Showing 1–15 of 200
Regulatory clearances
Predicate lineage
K083124
Cited as predicate by: K111647, K142624, K162199, K162313, K181559, K182542, K200759, K223254, K233001, K251672
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2024-06-17 | VAI | Voluntary action indicated | Medtronic Xomed, Inc. | 1 |
| 2021-10-29 | VAI | Voluntary action indicated | Medtronic Xomed, Inc. | 5 |
| 2015-09-21 | VAI | Voluntary action indicated | Medtronic Xomed, Inc. | 1 |
| 2012-07-03 | VAI | Voluntary action indicated | Medtronic Xomed, Inc. | 8 |
| 2012-06-06 | NAI | No action indicated | Medtronic Xomed, Inc. | 0 |
| 2010-08-05 | VAI | Voluntary action indicated | Medtronic Xomed, Inc. | 4 |
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