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 StatesT707613327466683
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) |
|---|---|---|
| 2024-10 | 1 | — |
| 2025-01 | 1 | — |
| 2025-04 | 1 | — |
| 2025-07 | 1 | — |
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 |
|---|---|---|---|---|
| 2025-07-29 | 3015967359-2025-99232 | Malfunction | Available | exact di |
| 2025-04-21 | 3015967359-2025-00909 | Malfunction | Available | exact di |
| 2025-01-22 | 3015967359-2025-00326 | Malfunction | Available | exact di |
| 2024-10-22 | 3015967359-2024-02210 | Malfunction | Available | exact di |
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2011-01-05 | NAI | No action indicated | Stryker Instruments | 0 |
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