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.
1 linked reportMalfunction 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2022-03 | 1 | 1 |
| 2023-07 | 0 | 1 |
| 2025-01 | 0 | 2 |
| 2025-03 | 0 | 1 |
| 2025-04 | 0 | 3 |
| 2025-12 | 0 | 1.5 |
| 2026-03 | 0 | 2 |
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2022-03-19 | 1526439-2022-00422 | Malfunction | Available | exact di |
Regulatory clearances
- 510(k)K141509Substantially equivalent (SESE) · 2014-08-22clearance family
Predicate lineage
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 |
|---|---|---|---|---|
| 2019-04-18 | NAI | No action indicated | DePuy Spine, Inc. | 0 |
| 2019-04-18 | NAI | No action indicated | DePuy Spine, Inc. | 0 |
| 2017-06-16 | NAI | No action indicated | DePuy Spine, Inc. | 0 |
| 2017-06-16 | NAI | No action indicated | DePuy Spine, Inc. | 0 |
| 2012-06-11 | NAI | No action indicated | DePuy Spine, Inc. | 0 |
| 2012-06-11 | NAI | No action indicated | DePuy Spine, Inc. | 0 |
| 2012-03-06 | NAI | No action indicated | Depuy Spine Inc | 0 |
| 2012-02-10 | VAI | Voluntary action indicated | DePuy Spine, Inc. | 2 |
| 2012-02-10 | VAI | Voluntary action indicated | DePuy Spine, Inc. | 2 |
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