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.
12 linked reportsMalfunction 12
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.55 |
| 2019-02 | 0 | 3.86 |
| 2019-03 | 0 | 3.18 |
| 2019-04 | 1 | 1.58 |
| 2019-05 | 0 | 1.81 |
| 2019-06 | 0 | 1.6 |
| 2019-07 | 0 | 2.48 |
| 2019-08 | 0 | 3.54 |
| 2019-09 | 1 | 2.29 |
| 2019-10 | 0 | 4.32 |
| 2019-11 | 0 | 5.27 |
| 2019-12 | 1 | 4.37 |
| 2020-01 | 0 | 4.12 |
| 2020-02 | 0 | 2.3 |
| 2020-03 | 0 | 3.85 |
| 2020-04 | 0 | 2.5 |
| 2020-05 | 1 | 1.41 |
| 2020-06 | 0 | 1.6 |
| 2020-07 | 0 | 3.71 |
| 2020-08 | 0 | 2.97 |
| 2020-09 | 0 | 2.5 |
| 2020-10 | 0 | 4.32 |
| 2020-11 | 0 | 2.44 |
| 2020-12 | 0 | 3.42 |
| 2021-01 | 0 | 1.33 |
| 2021-02 | 0 | 2.64 |
| 2021-03 | 0 | 2.96 |
| 2021-04 | 0 | 1.98 |
| 2021-05 | 0 | 2.15 |
| 2021-06 | 0 | 2.06 |
| 2021-07 | 0 | 3.76 |
| 2021-08 | 0 | 2.17 |
| 2021-09 | 0 | 4.18 |
| 2021-10 | 0 | 2 |
| 2021-11 | 0 | 2.29 |
| 2021-12 | 0 | 1.68 |
| 2022-01 | 0 | 2.04 |
| 2022-02 | 0 | 2.89 |
| 2022-03 | 0 | 1.63 |
| 2022-04 | 0 | 2.93 |
| 2022-05 | 0 | 2.68 |
| 2022-06 | 0 | 2.12 |
| 2022-07 | 0 | 1.93 |
| 2022-08 | 0 | 1.91 |
| 2022-09 | 0 | 2.08 |
| 2022-10 | 0 | 2.32 |
| 2022-11 | 0 | 2.41 |
| 2022-12 | 0 | 2.13 |
| 2023-01 | 0 | 2.65 |
| 2023-02 | 0 | 1.98 |
| 2023-03 | 0 | 2 |
| 2023-04 | 0 | 1.63 |
| 2023-05 | 0 | 2.03 |
| 2023-06 | 0 | 1.49 |
| 2023-07 | 0 | 1.68 |
| 2023-08 | 0 | 3.29 |
| 2023-09 | 0 | 3.56 |
| 2023-10 | 0 | 5 |
| 2023-11 | 2 | 5.14 |
| 2023-12 | 0 | 5.78 |
| 2024-01 | 0 | 3.49 |
| 2024-02 | 0 | 4.42 |
| 2024-03 | 0 | 6.29 |
| 2024-04 | 0 | 9.33 |
| 2024-05 | 0 | 8.26 |
| 2024-06 | 0 | 6.64 |
| 2024-07 | 0 | 9.16 |
| 2024-08 | 0 | 8.75 |
| 2024-09 | 0 | 15.18 |
| 2024-10 | 1 | 11.48 |
| 2024-11 | 1 | 9.62 |
| 2024-12 | 0 | 7.22 |
| 2025-01 | 0 | 6.53 |
| 2025-02 | 0 | 9.88 |
| 2025-03 | 0 | 15.99 |
| 2025-04 | 0 | 7.77 |
| 2025-05 | 0 | 6.45 |
| 2025-06 | 0 | 7.48 |
| 2025-07 | 0 | 11.44 |
| 2025-08 | 0 | 7.68 |
| 2025-09 | 1 | 6.75 |
| 2025-10 | 0 | 10.98 |
| 2025-11 | 2 | 9.31 |
| 2025-12 | 1 | 8.86 |
| 2026-01 | 0 | 6.61 |
| 2026-02 | 0 | 8.19 |
| 2026-03 | 0 | 8.72 |
| 2026-04 | 0 | 8.64 |
| 2026-05 | 0 | 13.19 |
| 2026-06 | 0 | 8.78 |
Failure-mode summaryAI-generated
12 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-12-28 | 1045254-2025-02843 | Malfunction | Available | exact di |
| 2025-11-18 | 1045254-2025-02586 | Malfunction | Available | exact di |
| 2025-11-17 | 1045254-2025-02579 | Malfunction | Available | exact di |
| 2025-09-11 | 1045254-2025-02131 | Malfunction | Available | exact di |
| 2024-11-06 | 1045254-2024-01927 | Malfunction | Available | exact di |
| 2024-10-01 | 1045254-2024-01674 | Malfunction | Available | exact di |
| 2023-11-21 | 1045254-2023-00980 | Malfunction | Available | exact di |
| 2023-11-09 | 1045254-2023-00934 | Malfunction | Available | exact di |
| 2020-05-28 | 1045254-2020-00264 | Malfunction | Available | exact di |
| 2019-12-02 | 1045254-2019-00643 | Malfunction | Available | exact di |
| 2019-09-24 | 1030489-2019-01058 | Malfunction | Available | model number |
| 2019-04-22 | 1030489-2019-00458 | Malfunction | Available | model number |
Regulatory clearances
Predicate lineage
K050798
Cited as predicate by: K142624
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 |
|---|---|---|---|---|
| 2026-02-06 | NAI | No action indicated | Medtronic Sofamor Danek USA Inc | 0 |
| 2017-10-26 | NAI | No action indicated | Medtronic Sofamor Danek USA, Inc | 0 |
| 2015-11-03 | VAI | Voluntary action indicated | Medtronic Sofamor Danek USA Inc | 0 |
| 2015-10-23 | VAI | Voluntary action indicated | Medtronic Sofamor Danek USA Inc | 1 |
| 2014-03-11 | VAI | Voluntary action indicated | Medtronic Sofamor Danek USA Inc | 0 |
| 2013-07-15 | NAI | No action indicated | Medtronic Sofamor Danek USA, Inc | 0 |
| 2013-07-15 | NAI | No action indicated | Medtronic Sofamor Danek USA Inc | 0 |
| 2012-06-06 | VAI | Voluntary action indicated | Medtronic Sofamor Danek USA Inc | 0 |
| 2011-02-23 | NAI | No action indicated | Medtronic Sofamor Danek Usa Inc | 0 |
| 2010-08-06 | VAI | Voluntary action indicated | Medtronic Sofamor Danek USA Inc | 0 |
| 2010-03-04 | VAI | Voluntary action indicated | Medtronic Sofamor Danek USA Inc | 0 |
| 2010-02-25 | NAI | No action indicated | Medtronic Sofamor Danek USA Inc | 0 |
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