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 reportsInjury 4
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.65 |
| 2019-02 | 0 | 1.49 |
| 2019-03 | 0 | 1.73 |
| 2019-04 | 0 | 1.87 |
| 2019-05 | 0 | 1.55 |
| 2019-06 | 0 | 1.25 |
| 2019-07 | 0 | 1.43 |
| 2019-08 | 0 | 1.45 |
| 2019-09 | 0 | 1.41 |
| 2019-10 | 0 | 1.5 |
| 2019-11 | 0 | 1.35 |
| 2019-12 | 0 | 1.42 |
| 2020-01 | 0 | 1.68 |
| 2020-02 | 0 | 1.39 |
| 2020-03 | 0 | 1.51 |
| 2020-04 | 0 | 1.46 |
| 2020-05 | 0 | 1.45 |
| 2020-06 | 0 | 1.45 |
| 2020-07 | 0 | 1.47 |
| 2020-08 | 0 | 1.29 |
| 2020-09 | 0 | 1.42 |
| 2020-10 | 0 | 1.32 |
| 2020-11 | 0 | 1.43 |
| 2020-12 | 0 | 1.6 |
| 2021-01 | 0 | 1.69 |
| 2021-02 | 0 | 1.36 |
| 2021-03 | 0 | 1.37 |
| 2021-04 | 0 | 1.32 |
| 2021-05 | 0 | 1.31 |
| 2021-06 | 0 | 1.4 |
| 2021-07 | 0 | 1.36 |
| 2021-08 | 0 | 1.34 |
| 2021-09 | 0 | 1.44 |
| 2021-10 | 0 | 1.42 |
| 2021-11 | 0 | 1.32 |
| 2021-12 | 0 | 1.41 |
| 2022-01 | 0 | 1.31 |
| 2022-02 | 0 | 1.3 |
| 2022-03 | 0 | 1.32 |
| 2022-04 | 0 | 1.44 |
| 2022-05 | 0 | 1.44 |
| 2022-06 | 0 | 1.47 |
| 2022-07 | 0 | 1.33 |
| 2022-08 | 0 | 1.46 |
| 2022-09 | 0 | 1.49 |
| 2022-10 | 0 | 1.36 |
| 2022-11 | 0 | 1.36 |
| 2022-12 | 0 | 1.34 |
| 2023-01 | 0 | 2.1 |
| 2023-02 | 0 | 1.52 |
| 2023-03 | 0 | 1.41 |
| 2023-04 | 0 | 1.39 |
| 2023-05 | 0 | 1.35 |
| 2023-06 | 0 | 1.33 |
| 2023-07 | 0 | 1.36 |
| 2023-08 | 0 | 1.29 |
| 2023-09 | 0 | 1.31 |
| 2023-10 | 0 | 1.27 |
| 2023-11 | 0 | 1.18 |
| 2023-12 | 0 | 1.18 |
| 2024-01 | 0 | 1.34 |
| 2024-02 | 0 | 1.3 |
| 2024-03 | 0 | 1.48 |
| 2024-04 | 0 | 1.13 |
| 2024-05 | 0 | 1.17 |
| 2024-06 | 0 | 1.28 |
| 2024-07 | 0 | 1.24 |
| 2024-08 | 0 | 1.23 |
| 2024-09 | 0 | 1.3 |
| 2024-10 | 0 | 1.39 |
| 2024-11 | 0 | 1.32 |
| 2024-12 | 0 | 1.27 |
| 2025-01 | 0 | 1.49 |
| 2025-02 | 0 | 1.27 |
| 2025-03 | 0 | 1.75 |
| 2025-04 | 0 | 1.61 |
| 2025-05 | 0 | 1.33 |
| 2025-06 | 0 | 1.54 |
| 2025-07 | 0 | 1.64 |
| 2025-08 | 0 | 1.36 |
| 2025-09 | 0 | 1.42 |
| 2025-10 | 0 | 1.56 |
| 2025-11 | 0 | 1.51 |
| 2025-12 | 0 | 1.54 |
| 2026-01 | 2 | 1.65 |
| 2026-02 | 0 | 1.3 |
| 2026-03 | 2 | 1.53 |
| 2026-04 | 0 | 1.59 |
| 2026-05 | 0 | 1.27 |
| 2026-06 | 0 | 1.32 |
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 |
|---|---|---|---|---|
| 2026-03-16 | 1722511-2026-00006 | Injury | Available | exact di |
| 2026-01-07 | 1722511-2026-00001 | Injury | Available | exact di |
Showing the most recent 2 of 4 linked reports.
Regulatory clearances
Predicate lineage
K050966
Cited as predicate by: K091967
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 |
|---|---|---|---|---|
| 2021-07-19 | NAI | No action indicated | Ortho Development Corporation | 0 |
| 2021-07-19 | NAI | No action indicated | Ortho Development Corporation | 0 |
| 2016-10-04 | NAI | No action indicated | Ortho Development Corporation | 0 |
| 2016-10-04 | NAI | No action indicated | Ortho Development Corporation | 0 |
| 2015-04-24 | NAI | No action indicated | Ortho Development Corporation | 0 |
| 2015-04-24 | NAI | No action indicated | Ortho Development Corporation | 0 |
| 2013-12-10 | NAI | No action indicated | Ortho Development Corporation | 0 |
| 2013-12-10 | NAI | No action indicated | Ortho Development Corporation | 0 |
| 2011-06-03 | VAI | Voluntary action indicated | Ortho Development Corporation | 4 |
| 2011-06-03 | VAI | Voluntary action indicated | Ortho Development Corporation | 4 |
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