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.
7 linked reportsMalfunction 5Injury 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.75 |
| 2019-02 | 0 | 1.53 |
| 2019-03 | 0 | 1.61 |
| 2019-04 | 0 | 1.66 |
| 2019-05 | 0 | 1.84 |
| 2019-06 | 0 | 1.85 |
| 2019-07 | 0 | 1.42 |
| 2019-08 | 0 | 2.01 |
| 2019-09 | 0 | 1.53 |
| 2019-10 | 0 | 1.8 |
| 2019-11 | 0 | 1.6 |
| 2019-12 | 0 | 1.76 |
| 2020-01 | 0 | 1.93 |
| 2020-02 | 0 | 2.15 |
| 2020-03 | 1 | 1.66 |
| 2020-04 | 0 | 1.67 |
| 2020-05 | 0 | 1.58 |
| 2020-06 | 0 | 1.94 |
| 2020-07 | 0 | 1.93 |
| 2020-08 | 0 | 1.82 |
| 2020-09 | 0 | 2 |
| 2020-10 | 0 | 2.08 |
| 2020-11 | 0 | 1.89 |
| 2020-12 | 2 | 1.81 |
| 2021-01 | 0 | 1.94 |
| 2021-02 | 0 | 1.85 |
| 2021-03 | 4 | 1.98 |
| 2021-04 | 0 | 1.89 |
| 2021-05 | 0 | 1.71 |
| 2021-06 | 0 | 1.56 |
| 2021-07 | 0 | 1.99 |
| 2021-08 | 0 | 2.16 |
| 2021-09 | 0 | 1.76 |
| 2021-10 | 0 | 1.88 |
| 2021-11 | 0 | 1.96 |
| 2021-12 | 0 | 1.99 |
| 2022-01 | 0 | 2.16 |
| 2022-02 | 0 | 2.19 |
| 2022-03 | 0 | 1.87 |
| 2022-04 | 0 | 2.09 |
| 2022-05 | 0 | 1.89 |
| 2022-06 | 0 | 2.15 |
| 2022-07 | 0 | 2.17 |
| 2022-08 | 0 | 2 |
| 2022-09 | 0 | 1.89 |
| 2022-10 | 0 | 1.83 |
| 2022-11 | 0 | 1.93 |
| 2022-12 | 0 | 1.83 |
| 2023-01 | 0 | 1.74 |
| 2023-02 | 0 | 1.81 |
| 2023-03 | 0 | 1.89 |
| 2023-04 | 0 | 1.89 |
| 2023-05 | 0 | 1.95 |
| 2023-06 | 0 | 2.13 |
| 2023-07 | 0 | 2 |
| 2023-08 | 0 | 1.62 |
| 2023-09 | 0 | 1.45 |
| 2023-10 | 0 | 1.55 |
| 2023-11 | 0 | 1.58 |
| 2023-12 | 0 | 1.38 |
| 2024-01 | 0 | 1.77 |
| 2024-02 | 0 | 1.7 |
| 2024-03 | 0 | 1.6 |
| 2024-04 | 0 | 1.77 |
| 2024-05 | 0 | 1.61 |
| 2024-06 | 0 | 1.88 |
| 2024-07 | 0 | 1.52 |
| 2024-08 | 0 | 1.67 |
| 2024-09 | 0 | 1.65 |
| 2024-10 | 0 | 1.63 |
| 2024-11 | 0 | 1.58 |
| 2024-12 | 0 | 1.62 |
| 2025-01 | 0 | 1.69 |
| 2025-02 | 0 | 1.57 |
| 2025-03 | 0 | 1.78 |
| 2025-04 | 0 | 1.7 |
| 2025-05 | 0 | 1.76 |
| 2025-06 | 0 | 1.78 |
| 2025-07 | 0 | 1.63 |
| 2025-08 | 0 | 1.6 |
| 2025-09 | 0 | 1.45 |
| 2025-10 | 0 | 1.56 |
| 2025-11 | 0 | 1.74 |
| 2025-12 | 0 | 2.07 |
| 2026-01 | 0 | 1.8 |
| 2026-02 | 0 | 1.73 |
| 2026-03 | 0 | 1.67 |
| 2026-04 | 0 | 1.7 |
| 2026-05 | 0 | 1.64 |
| 2026-06 | 0 | 1.65 |
Failure-mode summaryAI-generated
7 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2021-03-24 | 1038671-2021-00130 | Injury | Available | exact di |
| 2021-03-17 | 1038671-2021-00116 | Injury | Available | exact di |
| 2021-03-16 | 1038671-2021-00113 | Malfunction | Available | catalog number |
| 2020-12-08 | 1038671-2020-00641 | Malfunction | Available | catalog number |
| 2020-03-09 | 1038671-2020-00242 | Malfunction | Available | exact di |
Showing the most recent 5 of 7 linked reports.
Regulatory clearances
Predicate lineage
K042021
Cited as predicate by: K093599, K103419, K110706, K131298, K140063, K150568, K152267, K162567, K162726, K173388, K192097, K213546
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 |
|---|---|---|---|---|
| 2025-12-19 | WL | Warning Letter | Exactech Sarasota, Inc. | — |
| 2025-08-27 | OAI | Official action indicated | Exactech, Inc. | 9 |
| 2025-08-27 | OAI | Official action indicated | Exactech, Inc. | 9 |
| 2025-07-25 | OAI | Official action indicated | Exactech Sarasota, Inc. | 7 |
| 2024-10-09 | VAI | Voluntary action indicated | Exactech, Inc. | 0 |
| 2024-10-09 | VAI | Voluntary action indicated | Exactech, Inc. | 0 |
| 2024-01-19 | WL | Warning Letter | Exactech, Inc. | — |
| 2024-01-19 | WL | Warning Letter | Exactech, Inc. | — |
| 2023-09-26 | OAI | Official action indicated | Exactech, Inc. | 2 |
| 2023-09-26 | OAI | Official action indicated | Exactech, Inc. | 2 |
| 2021-11-17 | VAI | Voluntary action indicated | Exactech, Inc. | 4 |
| 2021-11-17 | VAI | Voluntary action indicated | Exactech, Inc. | 4 |
| 2020-01-31 | VAI | Voluntary action indicated | Exactech, Inc. | 7 |
| 2020-01-31 | VAI | Voluntary action indicated | Exactech, Inc. | 7 |
| 2017-03-10 | VAI | Voluntary action indicated | Exactech, Inc. | 7 |
| 2017-03-10 | VAI | Voluntary action indicated | Exactech, Inc. | 7 |
| 2015-07-16 | NAI | No action indicated | Exactech, Inc. | 0 |
| 2015-07-16 | NAI | No action indicated | Exactech, Inc. | 0 |
| 2014-08-25 | NAI | No action indicated | Exactech Sarasota, Inc. | 0 |
| 2012-12-11 | NAI | No action indicated | Exactech, Inc. | 0 |
| 2012-12-11 | NAI | No action indicated | Exactech, Inc. | 0 |
| 2010-03-25 | VAI | Voluntary action indicated | Exactech, Inc. | 0 |
| 2010-03-25 | VAI | Voluntary action indicated | Exactech, Inc. | 0 |
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