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.
14 linked reportsInjury 14
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 3.2 |
| 2019-02 | 0 | 2.73 |
| 2019-03 | 0 | 2.73 |
| 2019-04 | 0 | 2.64 |
| 2019-05 | 0 | 2.14 |
| 2019-06 | 0 | 1.88 |
| 2019-07 | 0 | 2.1 |
| 2019-08 | 0 | 2.11 |
| 2019-09 | 0 | 2.34 |
| 2019-10 | 0 | 2.35 |
| 2019-11 | 0 | 1.93 |
| 2019-12 | 1 | 2.38 |
| 2020-01 | 1 | 2.54 |
| 2020-02 | 0 | 2.53 |
| 2020-03 | 0 | 3.26 |
| 2020-04 | 0 | 2.33 |
| 2020-05 | 0 | 2.67 |
| 2020-06 | 0 | 1.89 |
| 2020-07 | 0 | 2.42 |
| 2020-08 | 0 | 1.86 |
| 2020-09 | 0 | 2.21 |
| 2020-10 | 0 | 2.56 |
| 2020-11 | 0 | 2.17 |
| 2020-12 | 1 | 2.11 |
| 2021-01 | 0 | 2.12 |
| 2021-02 | 0 | 1.93 |
| 2021-03 | 0 | 2.02 |
| 2021-04 | 0 | 1.94 |
| 2021-05 | 0 | 2.07 |
| 2021-06 | 1 | 2.35 |
| 2021-07 | 0 | 2.38 |
| 2021-08 | 0 | 2 |
| 2021-09 | 0 | 2.26 |
| 2021-10 | 0 | 2.02 |
| 2021-11 | 0 | 2.38 |
| 2021-12 | 0 | 2.49 |
| 2022-01 | 0 | 2.04 |
| 2022-02 | 0 | 2.76 |
| 2022-03 | 0 | 1.86 |
| 2022-04 | 0 | 2.3 |
| 2022-05 | 0 | 2 |
| 2022-06 | 0 | 2.11 |
| 2022-07 | 0 | 2 |
| 2022-08 | 0 | 2.16 |
| 2022-09 | 0 | 1.98 |
| 2022-10 | 0 | 2.05 |
| 2022-11 | 2 | 2.31 |
| 2022-12 | 0 | 2.22 |
| 2023-01 | 0 | 1.71 |
| 2023-02 | 1 | 1.89 |
| 2023-03 | 0 | 2.08 |
| 2023-04 | 0 | 1.93 |
| 2023-05 | 0 | 2.23 |
| 2023-06 | 0 | 2.28 |
| 2023-07 | 1 | 2.11 |
| 2023-08 | 0 | 2.18 |
| 2023-09 | 0 | 2.16 |
| 2023-10 | 1 | 1.47 |
| 2023-11 | 0 | 1.55 |
| 2023-12 | 0 | 1.57 |
| 2024-01 | 0 | 1.69 |
| 2024-02 | 0 | 1.81 |
| 2024-03 | 0 | 1.96 |
| 2024-04 | 0 | 1.64 |
| 2024-05 | 0 | 2.19 |
| 2024-06 | 0 | 1.84 |
| 2024-07 | 0 | 1.69 |
| 2024-08 | 0 | 1.78 |
| 2024-09 | 0 | 2.09 |
| 2024-10 | 0 | 1.71 |
| 2024-11 | 0 | 1.55 |
| 2024-12 | 0 | 1.52 |
| 2025-01 | 0 | 1.55 |
| 2025-02 | 0 | 1.45 |
| 2025-03 | 0 | 1.61 |
| 2025-04 | 0 | 1.76 |
| 2025-05 | 0 | 1.52 |
| 2025-06 | 0 | 1.73 |
| 2025-07 | 1 | 1.69 |
| 2025-08 | 1 | 1.63 |
| 2025-09 | 0 | 1.91 |
| 2025-10 | 0 | 1.74 |
| 2025-11 | 1 | 2.04 |
| 2025-12 | 0 | 1.96 |
| 2026-01 | 0 | 2.23 |
| 2026-02 | 0 | 1.7 |
| 2026-03 | 0 | 2.33 |
| 2026-04 | 0 | 1.77 |
| 2026-05 | 2 | 2.02 |
| 2026-06 | 0 | 1.65 |
Failure-mode summaryAI-generated
14 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-05-19 | 0002249697-2026-00429 | Injury | Available | exact di |
| 2026-05-11 | 0002249697-2026-00387 | Injury | Available | exact di |
| 2025-11-03 | 0002249697-2025-01287 | Injury | Available | exact di |
| 2025-08-05 | 0002249697-2025-00789 | Injury | Available | exact di |
| 2025-07-31 | 0002249697-2025-00772 | Injury | Available | exact di |
| 2023-10-11 | 0002249697-2023-01177 | Injury | Available | exact di |
| 2023-07-20 | 0002249697-2023-00799 | Injury | Available | exact di |
| 2023-02-02 | 0002249697-2023-00108 | Injury | Available | exact di |
| 2022-11-22 | 0002249697-2022-01720 | Injury | Available | exact di |
| 2022-11-07 | 0002249697-2022-01589 | Injury | Available | exact di |
| 2021-06-25 | 0002249697-2021-01078 | Injury | Available | exact di |
| 2020-12-18 | 0002249697-2020-02692 | Injury | Available | exact di |
| 2020-01-24 | 0002249697-2020-00164 | Injury | Available | exact di |
| 2019-12-13 | 0002249697-2019-04021 | Injury | Available | exact di |
Regulatory clearances
Predicate lineage
K023087
Cited as predicate by: K092138, K121029, K121055, K121056, K122015, K151008, K190100, K222056, K223528, K233261, K241059, K241716, K251665
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2023-12-01 | VAI | Voluntary action indicated | Howmedica Osteonics Corp. | 1 |
| 2021-06-22 | NAI | No action indicated | Howmedica Osteonics Corp. | 0 |
| 2015-03-09 | VAI | Voluntary action indicated | Howmedica Osteonics Corp. | 3 |
| 2013-04-16 | VAI | Voluntary action indicated | Howmedica Osteonics Corp. | 3 |
| 2010-01-15 | NAI | No action indicated | Howmedica Osteonics Corp. | 0 |
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