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.
2 linked reportsInjury 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-03 | 0 | 2 |
| 2019-07 | 0 | 3 |
| 2019-09 | 0 | 6 |
| 2019-12 | 0 | 1 |
| 2020-02 | 0 | 3 |
| 2020-07 | 0 | 2.5 |
| 2020-08 | 0 | 2 |
| 2020-10 | 0 | 3 |
| 2020-11 | 0 | 3 |
| 2020-12 | 0 | 3 |
| 2021-02 | 0 | 3 |
| 2021-04 | 0 | 2 |
| 2021-05 | 0 | 3 |
| 2021-08 | 0 | 3 |
| 2021-09 | 0 | 3 |
| 2022-02 | 0 | 3 |
| 2022-05 | 0 | 3.5 |
| 2022-10 | 0 | 4.5 |
| 2024-04 | 0 | 3 |
| 2026-06 | 2 | 2 |
Failure-mode summaryAI-generated
2 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-30 | 3010536692-2026-00235 | Injury | Available | catalog number |
Showing the most recent 1 of 2 linked reports.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2023-02-08 | NAI | No action indicated | MicroPort Orthopedics Inc. | 0 |
| 2023-02-08 | NAI | No action indicated | MicroPort Orthopedics Inc. | 0 |
| 2018-06-29 | VAI | Voluntary action indicated | MicroPort Orthopedics Inc. | 2 |
| 2018-06-29 | VAI | Voluntary action indicated | MicroPort Orthopedics Inc. | 2 |
| 2015-08-19 | VAI | Voluntary action indicated | MicroPort Orthopedics Inc. | 5 |
| 2015-08-19 | VAI | Voluntary action indicated | MicroPort Orthopedics Inc. | 5 |
| 2015-06-17 | WL | Warning Letter | MicroPort Orthopedics Inc. | — |
| 2015-06-17 | WL | Warning Letter | MicroPort Orthopedics Inc. | — |
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