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.
1 linked reportMalfunction 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2023-09 | 0 | 1 |
| 2024-03 | 1 | 1 |
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2024-03-13 | 0002031963-2024-00002 | Malfunction | Available | exact di |
Regulatory clearances
- 510(k)K100852Substantially equivalent (SESE) · 2010-05-06clearance family
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2016-03-03 | NAI | No action indicated | Stryker Communications | 0 |
| 2012-11-13 | NAI | No action indicated | Stryker Communications | 0 |
| 2012-03-02 | VAI | Voluntary action indicated | Stryker Communications | 2 |
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