Regulatory presence across jurisdictions
The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.
- United StatesEasytech Anatomical Shoulder System03701037301487
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.
13 linked reportsInjury 13
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2021-10 | 1 | — |
| 2021-12 | 2 | — |
| 2022-01 | 1 | — |
| 2022-03 | 1 | — |
| 2023-03 | 1 | — |
| 2023-05 | 1 | — |
| 2023-12 | 1 | — |
| 2024-02 | 1 | — |
| 2025-06 | 2 | — |
| 2026-05 | 1 | — |
| 2026-06 | 1 | — |
Failure-mode summaryAI-generated
13 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-24 | 3009532798-2026-00028 | Injury | Available | exact di |
| 2026-05-20 | 3014128390-2026-00016 | Injury | Available | exact di |
| 2025-06-25 | 3009532798-2025-00045 | Injury | Available | exact di |
| 2025-06-19 | 3009532798-2025-00043 | Injury | Available | exact di |
| 2024-02-08 | 3009532798-2024-00004 | Injury | Available | exact di |
| 2023-12-15 | 3009532798-2023-00126 | Injury | Available | exact di |
| 2023-05-24 | 3009532798-2023-00036 | Injury | Available | exact di |
| 2023-03-02 | 3009532798-2023-00009 | Injury | Available | exact di |
| 2022-03-03 | 3009532798-2022-00017 | Injury | Available | exact di |
| 2022-01-12 | 3009532798-2021-00256 | Injury | Available | exact di |
| 2021-12-24 | 3009532798-2021-00206 | Injury | Available | exact di |
| 2021-12-16 | 3009532798-2021-00202 | Injury | Available | exact di |
| 2021-10-22 | 3009532798-2021-00154 | Injury | Available | exact di |
Regulatory clearances
None linked.
Manufacturer compliance record
None in the loaded window.
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