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.
3 linked reportsInjury 3
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-02 | 0 | 1 |
| 2019-03 | 0 | 1 |
| 2019-04 | 0 | 1 |
| 2019-05 | 0 | 1.5 |
| 2019-06 | 0 | 1.17 |
| 2019-07 | 0 | 2 |
| 2019-08 | 0 | 6.67 |
| 2019-09 | 0 | 1 |
| 2019-10 | 0 | 3.56 |
| 2019-11 | 0 | 1.33 |
| 2019-12 | 0 | 1 |
| 2020-01 | 0 | 1.33 |
| 2020-02 | 0 | 2 |
| 2020-03 | 0 | 1.5 |
| 2020-04 | 0 | 1.5 |
| 2020-05 | 0 | 1.57 |
| 2020-06 | 0 | 1 |
| 2020-07 | 0 | 1.33 |
| 2020-08 | 0 | 1.42 |
| 2020-09 | 0 | 1 |
| 2020-10 | 0 | 1.58 |
| 2020-11 | 0 | 1 |
| 2020-12 | 0 | 2 |
| 2021-01 | 0 | 1.25 |
| 2021-02 | 0 | 1.5 |
| 2021-03 | 0 | 1.71 |
| 2021-04 | 0 | 1 |
| 2021-05 | 0 | 1 |
| 2021-06 | 0 | 4.05 |
| 2021-07 | 0 | 1.25 |
| 2021-08 | 0 | 1 |
| 2021-09 | 0 | 1.86 |
| 2021-10 | 0 | 1 |
| 2021-11 | 0 | 1 |
| 2021-12 | 0 | 1.38 |
| 2022-01 | 0 | 1.25 |
| 2022-02 | 0 | 1.5 |
| 2022-03 | 0 | 1.64 |
| 2022-04 | 0 | 1.2 |
| 2022-05 | 0 | 1.85 |
| 2022-06 | 0 | 1.4 |
| 2022-07 | 0 | 1.29 |
| 2022-08 | 0 | 1.43 |
| 2022-09 | 0 | 2.11 |
| 2022-10 | 0 | 1.33 |
| 2022-11 | 0 | 2 |
| 2022-12 | 0 | 1 |
| 2023-02 | 0 | 1 |
| 2023-03 | 0 | 1.57 |
| 2023-04 | 0 | 1 |
| 2023-05 | 0 | 1.5 |
| 2023-06 | 0 | 1 |
| 2023-07 | 0 | 1 |
| 2023-08 | 0 | 5.78 |
| 2023-09 | 0 | 1 |
| 2023-10 | 0 | 1.6 |
| 2023-11 | 0 | 1 |
| 2023-12 | 0 | 1.25 |
| 2024-01 | 0 | 4 |
| 2024-02 | 0 | 1.5 |
| 2024-03 | 0 | 1.5 |
| 2024-04 | 0 | 1.5 |
| 2024-05 | 0 | 1.33 |
| 2024-06 | 0 | 1.5 |
| 2024-07 | 0 | 1.67 |
| 2024-08 | 0 | 2 |
| 2024-09 | 0 | 1.67 |
| 2024-10 | 0 | 1.2 |
| 2024-11 | 0 | 1.6 |
| 2024-12 | 0 | 1.71 |
| 2025-01 | 1 | 1.43 |
| 2025-02 | 1 | 1.78 |
| 2025-03 | 0 | 1.4 |
| 2025-04 | 0 | 1.88 |
| 2025-05 | 1 | 1.25 |
| 2025-06 | 0 | 1.6 |
| 2025-07 | 0 | 2.4 |
| 2025-08 | 0 | 1.67 |
| 2025-09 | 0 | 1.33 |
| 2025-10 | 0 | 1.5 |
| 2025-11 | 0 | 1.83 |
| 2025-12 | 0 | 1.67 |
| 2026-01 | 0 | 1.38 |
| 2026-02 | 0 | 1.38 |
| 2026-03 | 0 | 1.63 |
| 2026-04 | 0 | 1.38 |
| 2026-05 | 0 | 1.71 |
| 2026-06 | 0 | 1.89 |
Failure-mode summaryAI-generated
3 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-05-21 | 2031966-2025-00091 | Injury | Available | model number |
| 2025-02-18 | 2031966-2025-00021 | Injury | Available | model number |
| 2025-01-14 | 2031966-2025-00011 | Injury | Available | model number |
Regulatory clearances
- 510(k)K173030Substantially equivalent (SESE) · 2017-11-21clearance family
Predicate lineage
- K173030
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 |
|---|---|---|---|---|
| 2024-05-06 | VAI | Voluntary action indicated | NuVasive Specialized Orthopedics, Inc. | 12 |
| 2024-01-18 | NAI | No action indicated | Nuvasive PR, Inc. | 0 |
| 2019-12-09 | NAI | No action indicated | Nuvasive PR, Inc. | 0 |
| 2019-07-29 | NAI | No action indicated | NuVasive, Inc | 0 |
| 2017-05-31 | NAI | No action indicated | Nuvasive PR, Inc. | 0 |
| 2017-05-26 | VAI | Voluntary action indicated | NuVasive Inc | 2 |
| 2017-05-26 | VAI | Voluntary action indicated | NuVasive Inc | 2 |
| 2017-05-04 | VAI | Voluntary action indicated | NuVasive, Inc | 3 |
| 2016-10-26 | VAI | Voluntary action indicated | Nuvasive Inc | 2 |
| 2014-11-19 | NAI | No action indicated | NuVasive Inc | 0 |
| 2014-11-19 | NAI | No action indicated | NuVasive Inc | 0 |
| 2014-08-27 | NAI | No action indicated | Nuvasive Inc | 4 |
| 2014-04-01 | NAI | No action indicated | Nuvasive PR, Inc. | 0 |
| 2014-02-20 | NAI | No action indicated | NuVasive Specialized Orthopedics, Inc. | 0 |
| 2014-02-05 | NAI | No action indicated | NuVasive Inc | 0 |
| 2014-02-05 | NAI | No action indicated | NuVasive Inc | 0 |
| 2013-03-12 | WL | Warning Letter | NuVasive Inc | — |
| 2013-03-12 | WL | Warning Letter | NuVasive Inc | — |
| 2012-11-02 | OAI | Official action indicated | NuVasive Inc | 0 |
| 2012-11-02 | OAI | Official action indicated | NuVasive Inc | 0 |
| 2012-02-10 | NAI | No action indicated | NuVasive Inc | 0 |
| 2012-02-10 | NAI | No action indicated | NuVasive Inc | 0 |
Similar devices
- Anterior Cervical Interbody Fusion Device PRECISION SPINE, INC.
- Anterior Cervical Interbody Fusion Device PRECISION SPINE, INC.
- """12(w) x 15(d) Saber-C Bodies (PEEK) """ ELEVATION SPINE, INC.
- """12(w) x 15(d) Saber-C Bodies (PEEK) """ ELEVATION SPINE, INC.
- """12(w) x 15(d) Saber-C Bodies (PEEK) """ ELEVATION SPINE, INC.
- """12(w) x 15(d) Saber-C Bodies (PEEK) """ ELEVATION SPINE, INC.
- """12(w) x 15(d) Saber-C Bodies (PEEK) """ ELEVATION SPINE, INC.
- """12(w) x 15(d) Saber-C Bodies (PEEK) """ ELEVATION SPINE, INC.
- """12(w) x 15(d) Saber-C Bodies (PEEK) """ ELEVATION SPINE, INC.
- """12(w) x 15(d) Saber-C Bodies (PEEK) """ ELEVATION SPINE, INC.
- """12(w) x 15(d) Saber-C Bodies (PEEK) """ ELEVATION SPINE, INC.
- """12(w) x 15(d) Saber-C Bodies (PEEK) """ ELEVATION SPINE, INC.
Select up to two to place side-by-side with this device.