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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 StatesiBur07613327501155
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.

11 linked reportsMalfunction 11
12232022-04: 2 reports for this device2022-07: 3 reports for this device2022-09: 1 reports for this device2023-05: 1 reports for this device2023-06: 1 reports for this device2024-01: 1 reports for this device2025-07: 1 reports for this device2025-10: 1 reports for this device0407090506010710
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2022-042—
2022-073—
2022-091—
2023-051—
2023-061—
2024-011—
2025-071—
2025-101—
This device (reports/month)Average device in its product code (reports/device/month)
Failure-mode summaryAI-generated

11 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2025-10-233015967359-2025-99284MalfunctionAvailableexact di
2025-07-293015967359-2025-99250MalfunctionAvailableexact di
2024-01-223015967359-2024-00232MalfunctionAvailableexact di
2023-06-233015967359-2023-01347MalfunctionAvailableexact di
2023-05-263015967359-2023-01193MalfunctionAvailableexact di
2022-09-160001811755-2022-00045MalfunctionAvailableexact di
2022-07-110001811755-2022-00027MalfunctionAvailableexact di
2022-07-110001811755-2022-00025MalfunctionAvailableexact di
2022-07-110001811755-2022-00026MalfunctionAvailableexact di
2022-04-150001811755-2022-00013MalfunctionAvailableexact di
2022-04-150001811755-2022-00014MalfunctionAvailableexact di
Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2011-01-05NAINo action indicatedStryker Instruments0
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