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.
15 linked reportsInjury 9Malfunction 6
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-06 | 4 | 3 |
| 2019-07 | 0 | 2 |
| 2019-08 | 0 | 2 |
| 2019-09 | 2 | 2 |
| 2019-12 | 0 | 1 |
| 2020-02 | 0 | 2 |
| 2020-03 | 0 | 2 |
| 2020-06 | 0 | 2 |
| 2020-07 | 0 | 1 |
| 2021-02 | 0 | 1 |
| 2021-03 | 0 | 2 |
| 2021-04 | 0 | 2 |
| 2021-12 | 0 | 2 |
| 2022-02 | 2 | 2 |
| 2022-03 | 2 | 2.8 |
| 2022-05 | 2 | 2 |
| 2022-06 | 0 | 2 |
| 2022-08 | 0 | 2 |
| 2022-09 | 0 | 2 |
| 2023-01 | 0 | 2 |
| 2023-02 | 0 | 2 |
| 2023-06 | 0 | 2 |
| 2023-07 | 2 | 2 |
| 2024-04 | 0 | 2 |
| 2024-05 | 0 | 4 |
| 2025-02 | 0 | 2 |
| 2025-03 | 0 | 1 |
| 2025-04 | 0 | 1 |
| 2025-08 | 0 | 1 |
| 2025-09 | 0 | 1 |
| 2025-12 | 1 | 1 |
| 2026-02 | 0 | 1 |
| 2026-05 | 0 | 1 |
Failure-mode summaryAI-generated
15 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-12-08 | 9616086-2025-00073 | Injury | Available | exact di |
| 2023-07-14 | 9616086-2023-00055 | Injury | Available | exact di |
| 2022-05-23 | 9616086-2022-00013 | Injury | Available | exact di |
| 2022-03-24 | 9616086-2022-00009 | Malfunction | Available | exact di |
| 2022-02-09 | 9616086-2022-00002 | Malfunction | Available | exact di |
| 2019-09-06 | 9616086-2019-00062 | Malfunction | Available | exact di |
| 2019-06-26 | 9616086-2019-00030 | Injury | Available | exact di |
| 2019-06-25 | 9616086-2019-00026 | Injury | Available | exact di |
Showing the most recent 8 of 15 linked reports.
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2022-04-29 | NAI | No action indicated | DJO, LLC | 0 |
| 2022-04-29 | NAI | No action indicated | DJO, LLC | 0 |
| 2017-09-26 | VAI | Voluntary action indicated | DJO, LLC | 3 |
| 2017-09-26 | VAI | Voluntary action indicated | DJO, LLC | 4 |
| 2017-09-26 | VAI | Voluntary action indicated | DJO, LLC | 4 |
| 2017-09-26 | VAI | Voluntary action indicated | DJO, LLC | 3 |
| 2013-09-06 | VAI | Voluntary action indicated | DJO, LLC | 6 |
| 2013-09-06 | VAI | Voluntary action indicated | DJO, LLC | 6 |
| 2011-07-14 | VAI | Voluntary action indicated | DJO, LLC | 4 |
| 2011-07-14 | VAI | Voluntary action indicated | DJO, LLC | 4 |
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