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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 StatesiBur07613327501186
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.

19 linked reportsMalfunction 18Injury 1
12342022-09: 3 reports for this device2023-03: 2 reports for this device2023-04: 1 reports for this device2023-06: 2 reports for this device2023-07: 4 reports for this device2023-09: 1 reports for this device2023-10: 1 reports for this device2024-01: 1 reports for this device2024-02: 1 reports for this device2024-05: 1 reports for this device2024-08: 1 reports for this device2026-01: 1 reports for this device090304060709100102050801
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2022-093—
2023-032—
2023-041—
2023-062—
2023-074—
2023-091—
2023-101—
2024-011—
2024-021—
2024-051—
2024-081—
2026-011—
This device (reports/month)Average device in its product code (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2026-01-233015967359-2026-99106MalfunctionAvailableexact di
2024-08-283015967359-2024-01743MalfunctionAvailableexact di
2024-05-223015967359-2024-01077MalfunctionAvailableexact di
2024-02-203015967359-2024-00405MalfunctionAvailableexact di
2024-01-223015967359-2024-00160MalfunctionAvailableexact di
2023-10-093015967359-2023-02079InjuryAvailableexact di
2023-09-123015967359-2023-01943MalfunctionAvailableexact di
2023-07-123015967359-2023-01430MalfunctionAvailableexact di
2023-07-123015967359-2023-01435MalfunctionAvailableexact di
2023-07-123015967359-2023-01436MalfunctionAvailableexact di
2023-07-123015967359-2023-01431MalfunctionAvailableexact di
2023-06-193015967359-2023-01324MalfunctionAvailableexact di
2023-06-153015967359-2023-01308MalfunctionAvailableexact di
2023-04-133015967359-2023-00726MalfunctionAvailableexact di
2023-03-293015967359-2023-00642MalfunctionAvailableexact di
Showing 1–15 of 19
Regulatory clearances

None linked.

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