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.
28 linked reportsMalfunction 27Injury 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.54 |
| 2019-02 | 0 | 1.22 |
| 2019-03 | 0 | 1.69 |
| 2019-04 | 0 | 1.46 |
| 2019-05 | 0 | 1.6 |
| 2019-06 | 0 | 1.57 |
| 2019-07 | 0 | 1.65 |
| 2019-08 | 0 | 1.36 |
| 2019-09 | 0 | 1.32 |
| 2019-10 | 0 | 1.83 |
| 2019-11 | 0 | 1.58 |
| 2019-12 | 0 | 1.36 |
| 2020-01 | 0 | 1.67 |
| 2020-02 | 0 | 1.73 |
| 2020-03 | 0 | 1.45 |
| 2020-04 | 0 | 1.43 |
| 2020-05 | 0 | 1.64 |
| 2020-06 | 0 | 1.84 |
| 2020-07 | 0 | 1.85 |
| 2020-08 | 0 | 1.63 |
| 2020-09 | 0 | 2.52 |
| 2020-10 | 0 | 2.05 |
| 2020-11 | 0 | 2.1 |
| 2020-12 | 0 | 1.76 |
| 2021-01 | 0 | 1.7 |
| 2021-02 | 0 | 1.72 |
| 2021-03 | 0 | 2 |
| 2021-04 | 0 | 1.55 |
| 2021-05 | 0 | 1.6 |
| 2021-06 | 0 | 2.23 |
| 2021-07 | 0 | 1.73 |
| 2021-08 | 0 | 2.21 |
| 2021-09 | 0 | 1.72 |
| 2021-10 | 0 | 2.11 |
| 2021-11 | 0 | 1.84 |
| 2021-12 | 0 | 2.54 |
| 2022-01 | 0 | 3.14 |
| 2022-02 | 0 | 2.62 |
| 2022-03 | 1 | 1.78 |
| 2022-04 | 0 | 1.76 |
| 2022-05 | 1 | 2.13 |
| 2022-06 | 0 | 1.79 |
| 2022-07 | 0 | 2.21 |
| 2022-08 | 1 | 1.86 |
| 2022-09 | 0 | 1.78 |
| 2022-10 | 0 | 1.87 |
| 2022-11 | 0 | 1.93 |
| 2022-12 | 0 | 1.7 |
| 2023-01 | 0 | 2.44 |
| 2023-02 | 0 | 2.05 |
| 2023-03 | 0 | 1.71 |
| 2023-04 | 0 | 1.81 |
| 2023-05 | 1 | 2.04 |
| 2023-06 | 0 | 1.75 |
| 2023-07 | 0 | 2.04 |
| 2023-08 | 1 | 1.73 |
| 2023-09 | 0 | 1.97 |
| 2023-10 | 0 | 1.85 |
| 2023-11 | 2 | 10.03 |
| 2023-12 | 1 | 3.95 |
| 2024-01 | 0 | 1.86 |
| 2024-02 | 0 | 2.13 |
| 2024-03 | 0 | 1.9 |
| 2024-04 | 0 | 1.36 |
| 2024-05 | 0 | 1.58 |
| 2024-06 | 0 | 1.79 |
| 2024-07 | 0 | 1.93 |
| 2024-08 | 0 | 2.27 |
| 2024-09 | 0 | 1.9 |
| 2024-10 | 0 | 2.13 |
| 2024-11 | 0 | 1.74 |
| 2024-12 | 0 | 1.69 |
| 2025-01 | 0 | 1.85 |
| 2025-02 | 0 | 1.66 |
| 2025-03 | 1 | 1.66 |
| 2025-04 | 1 | 1.6 |
| 2025-05 | 0 | 1.65 |
| 2025-06 | 2 | 2.02 |
| 2025-07 | 2 | 1.81 |
| 2025-08 | 0 | 1.61 |
| 2025-09 | 1 | 1.59 |
| 2025-10 | 0 | 1.71 |
| 2025-11 | 3 | 2.03 |
| 2025-12 | 0 | 1.85 |
| 2026-01 | 3 | 1.94 |
| 2026-02 | 2 | 1.53 |
| 2026-03 | 4 | 2.76 |
| 2026-04 | 1 | 1.57 |
| 2026-05 | 0 | 1.58 |
| 2026-06 | 0 | 1.6 |
Failure-mode summaryAI-generated
28 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-04-14 | 3003120897-2026-00687 | Malfunction | Available | model number |
| 2026-03-11 | 3003120897-2026-00400 | Malfunction | Available | model number |
| 2026-03-11 | 3003120897-2026-00399 | Malfunction | Available | model number |
| 2026-03-02 | 3003120897-2026-00327 | Malfunction | Available | model number |
| 2026-03-02 | 3003120897-2026-00321 | Malfunction | Available | model number |
| 2026-02-06 | 3003120897-2026-00199 | Malfunction | Available | model number |
| 2026-02-06 | 3003120897-2026-00201 | Malfunction | Available | model number |
| 2026-01-06 | 3003120897-2026-00030 | Malfunction | Available | model number |
| 2026-01-04 | 3003120897-2026-00006 | Malfunction | Available | model number |
| 2026-01-04 | 3003120897-2026-00005 | Malfunction | Available | model number |
| 2025-11-24 | 3003120897-2025-00609 | Malfunction | Available | model number |
| 2025-11-18 | 3003120897-2025-00590 | Malfunction | Available | model number |
| 2025-11-11 | 3003120897-2025-00546 | Malfunction | Available | model number |
| 2025-09-30 | 3003120897-2025-00299 | Malfunction | Available | model number |
| 2025-07-28 | 1030489-2025-02513 | Malfunction | Available | model number |
Showing 1–15 of 28
Regulatory clearances
Predicate lineage
- K171689
Cited as predicate by: K182119, K190959, K191788, K201267, K210425, K214010
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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