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.
4 linked reportsMalfunction 4
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1 |
| 2019-02 | 0 | 1 |
| 2019-03 | 0 | 2 |
| 2019-04 | 0 | 1.71 |
| 2019-05 | 0 | 1.56 |
| 2019-06 | 0 | 1.25 |
| 2019-07 | 0 | 1.67 |
| 2019-08 | 0 | 3 |
| 2019-09 | 0 | 1.67 |
| 2019-10 | 0 | 2 |
| 2019-11 | 0 | 1.2 |
| 2019-12 | 0 | 1.5 |
| 2020-01 | 0 | 8 |
| 2020-02 | 0 | 1.4 |
| 2020-03 | 0 | 1.2 |
| 2020-04 | 0 | 1.2 |
| 2020-05 | 0 | 1.33 |
| 2020-06 | 0 | 1 |
| 2020-07 | 0 | 2.17 |
| 2020-08 | 0 | 1 |
| 2020-09 | 0 | 2.33 |
| 2020-10 | 0 | 1.63 |
| 2020-11 | 0 | 1.33 |
| 2020-12 | 0 | 1.33 |
| 2021-01 | 0 | 1.25 |
| 2021-02 | 0 | 3.5 |
| 2021-03 | 0 | 1.5 |
| 2021-04 | 0 | 1 |
| 2021-05 | 0 | 3.92 |
| 2021-06 | 0 | 1.25 |
| 2021-07 | 0 | 1 |
| 2021-08 | 0 | 1.67 |
| 2021-09 | 0 | 1.5 |
| 2021-10 | 0 | 1 |
| 2021-11 | 1 | 1 |
| 2021-12 | 0 | 2 |
| 2022-01 | 0 | 1 |
| 2022-02 | 0 | 1 |
| 2022-03 | 0 | 1.14 |
| 2022-04 | 0 | 1 |
| 2022-05 | 0 | 1.4 |
| 2022-06 | 0 | 1.78 |
| 2022-07 | 0 | 1.14 |
| 2022-08 | 0 | 1.13 |
| 2022-09 | 0 | 2 |
| 2022-10 | 0 | 1 |
| 2022-11 | 0 | 1.33 |
| 2022-12 | 0 | 2.25 |
| 2023-01 | 0 | 3 |
| 2023-02 | 0 | 2 |
| 2023-03 | 0 | 2.83 |
| 2023-04 | 0 | 2 |
| 2023-05 | 0 | 1.33 |
| 2023-06 | 0 | 1.67 |
| 2023-07 | 0 | 1.5 |
| 2023-08 | 0 | 1.36 |
| 2023-10 | 0 | 2 |
| 2023-11 | 0 | 1 |
| 2023-12 | 0 | 1.5 |
| 2024-01 | 0 | 1.57 |
| 2024-02 | 0 | 1.5 |
| 2024-03 | 2 | 1.88 |
| 2024-04 | 0 | 2 |
| 2024-05 | 0 | 1.77 |
| 2024-06 | 0 | 3.38 |
| 2024-07 | 0 | 1 |
| 2024-08 | 0 | 1.2 |
| 2024-09 | 0 | 1.57 |
| 2024-10 | 0 | 1.5 |
| 2024-11 | 0 | 1.25 |
| 2024-12 | 0 | 1.25 |
| 2025-01 | 0 | 1.5 |
| 2025-02 | 0 | 2.2 |
| 2025-03 | 0 | 2.56 |
| 2025-04 | 0 | 1.75 |
| 2025-05 | 0 | 1.8 |
| 2025-06 | 0 | 2.4 |
| 2025-07 | 0 | 2.11 |
| 2025-08 | 0 | 1.4 |
| 2025-09 | 0 | 1.75 |
| 2025-10 | 1 | 1.57 |
| 2025-11 | 0 | 2.2 |
| 2025-12 | 0 | 1.4 |
| 2026-01 | 0 | 1.71 |
| 2026-02 | 0 | 1.71 |
| 2026-03 | 0 | 1.56 |
| 2026-04 | 0 | 1.25 |
| 2026-05 | 0 | 4 |
| 2026-06 | 0 | 3.5 |
Failure-mode summaryAI-generated
4 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-10-28 | 3004142400-2025-00265 | Malfunction | Available | exact di |
| 2024-03-05 | 3004142400-2023-00124 | Malfunction | Available | exact di |
| 2024-03-05 | 3004142400-2023-00125 | Malfunction | Available | exact di |
| 2021-11-07 | 3004142400-2021-00210 | Malfunction | Available | exact di |
Regulatory clearances
Predicate lineage
Cited as predicate by: K180909, K190885, K191243, K191477, K200087, K201073, K202065, K203076, K210382, K211417, K223837, K253876
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 |
|---|---|---|---|---|
| 2025-10-16 | VAI | Voluntary action indicated | Globus Medical, Inc. | 1 |
| 2025-10-16 | VAI | Voluntary action indicated | Globus Medical, Inc. | 1 |
| 2025-08-13 | OAI | Official action indicated | Nevro Corporation | 6 |
| 2025-03-25 | NAI | No action indicated | Nuvasive Manufacturing LLC. | 0 |
| 2024-07-15 | WL | Warning Letter | Globus Medical, Inc. | — |
| 2024-07-15 | WL | Warning Letter | Globus Medical, Inc. | — |
| 2024-03-07 | OAI | Official action indicated | Globus Medical, Inc. | 6 |
| 2024-03-07 | OAI | Official action indicated | Globus Medical, Inc. | 6 |
| 2023-12-20 | VAI | Voluntary action indicated | Nevro Corporation | 1 |
| 2022-07-29 | NAI | No action indicated | Nevro Medical SRL | 0 |
| 2022-04-26 | NAI | No action indicated | Nevro Corporation | 0 |
| 2019-10-23 | NAI | No action indicated | Globus Medical, Inc. | 0 |
| 2019-10-23 | NAI | No action indicated | Globus Medical, Inc. | 0 |
| 2019-09-27 | VAI | Voluntary action indicated | Globus Medical, Inc. | 7 |
| 2019-09-27 | VAI | Voluntary action indicated | Globus Medical, Inc. | 7 |
| 2019-03-21 | NAI | No action indicated | Nevro Corporation | 0 |
| 2019-02-13 | VAI | Voluntary action indicated | Globus Medical, Inc. | 2 |
| 2019-02-13 | VAI | Voluntary action indicated | Globus Medical, Inc. | 2 |
| 2018-03-16 | NAI | No action indicated | Nevro Corporation | 0 |
| 2017-11-03 | VAI | Voluntary action indicated | Nevro Corporation | 5 |
| 2017-09-25 | NAI | No action indicated | Globus Medical, Inc. | 0 |
| 2017-09-25 | NAI | No action indicated | Globus Medical, Inc. | 0 |
| 2013-09-26 | WL | Warning Letter | Globus Medical, Inc. | — |
| 2013-09-26 | WL | Warning Letter | Globus Medical, Inc. | — |
Similar devices
- """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.
- """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.