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.
200 linked reportsMalfunction 199Injury 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.6 |
| 2019-02 | 0 | 3.59 |
| 2019-03 | 0 | 3.95 |
| 2019-04 | 0 | 3.38 |
| 2019-05 | 0 | 3.72 |
| 2019-06 | 0 | 3.6 |
| 2019-07 | 0 | 3.12 |
| 2019-08 | 0 | 4.2 |
| 2019-09 | 0 | 3.57 |
| 2019-10 | 0 | 3.61 |
| 2019-11 | 1 | 4.18 |
| 2019-12 | 0 | 4.78 |
| 2020-01 | 0 | 3.71 |
| 2020-02 | 0 | 4.11 |
| 2020-03 | 0 | 5.18 |
| 2020-04 | 1 | 3.08 |
| 2020-05 | 0 | 3.01 |
| 2020-06 | 0 | 3.69 |
| 2020-07 | 0 | 3.49 |
| 2020-08 | 1 | 3.41 |
| 2020-09 | 0 | 4.23 |
| 2020-10 | 2 | 3.8 |
| 2020-11 | 0 | 3.97 |
| 2020-12 | 2 | 4.02 |
| 2021-01 | 0 | 3.21 |
| 2021-02 | 0 | 3.73 |
| 2021-03 | 1 | 3.71 |
| 2021-04 | 0 | 3.14 |
| 2021-05 | 0 | 3.48 |
| 2021-06 | 0 | 3.41 |
| 2021-07 | 0 | 3.24 |
| 2021-08 | 0 | 3.63 |
| 2021-09 | 0 | 3.29 |
| 2021-10 | 0 | 2.74 |
| 2021-11 | 0 | 3.15 |
| 2021-12 | 0 | 3.24 |
| 2022-01 | 0 | 2.88 |
| 2022-02 | 0 | 3.24 |
| 2022-03 | 1 | 3.62 |
| 2022-04 | 1 | 2.71 |
| 2022-05 | 0 | 3.27 |
| 2022-06 | 2 | 3.84 |
| 2022-07 | 0 | 2.86 |
| 2022-08 | 1 | 3.38 |
| 2022-09 | 2 | 4.15 |
| 2022-10 | 0 | 3.45 |
| 2022-11 | 1 | 3.77 |
| 2022-12 | 0 | 4.11 |
| 2023-01 | 0 | 2.95 |
| 2023-02 | 1 | 3.42 |
| 2023-03 | 0 | 3.4 |
| 2023-04 | 0 | 2.74 |
| 2023-05 | 0 | 3.98 |
| 2023-06 | 0 | 3.63 |
| 2023-07 | 0 | 2.98 |
| 2023-08 | 0 | 3.43 |
| 2023-09 | 0 | 3.59 |
| 2023-10 | 5 | 3.16 |
| 2023-11 | 0 | 4.98 |
| 2023-12 | 6 | 4.51 |
| 2024-01 | 3 | 3.32 |
| 2024-02 | 4 | 4.44 |
| 2024-03 | 6 | 4.56 |
| 2024-04 | 2 | 4.25 |
| 2024-05 | 2 | 5.29 |
| 2024-06 | 4 | 5.06 |
| 2024-07 | 2 | 4.14 |
| 2024-08 | 3 | 5.5 |
| 2024-09 | 2 | 7.47 |
| 2024-10 | 6 | 5 |
| 2024-11 | 0 | 5.9 |
| 2024-12 | 3 | 5.27 |
| 2025-01 | 1 | 3.75 |
| 2025-02 | 6 | 5.92 |
| 2025-03 | 2 | 6.61 |
| 2025-04 | 3 | 3.62 |
| 2025-05 | 2 | 4.66 |
| 2025-06 | 2 | 5.33 |
| 2025-07 | 10 | 4.7 |
| 2025-08 | 2 | 4.59 |
| 2025-09 | 6 | 4.77 |
| 2025-10 | 18 | 4.76 |
| 2025-11 | 30 | 6.48 |
| 2025-12 | 23 | 6.2 |
| 2026-01 | 6 | 3.77 |
| 2026-02 | 8 | 4.74 |
| 2026-03 | 6 | 5.51 |
| 2026-04 | 6 | 5.51 |
| 2026-05 | 2 | 6.09 |
| 2026-06 | 2 | 11.11 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2025-07-17 | Z-2461-2025 | Class II | Open, Classified | Due to out of the box wobble of the driver.Distribution: U.S.: AZ, CA, CO, CT, FL, GA, IA, IL, IN, LA, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OR, SC, TN, TX, O.U.S.: Canada, China, Croatia, France, Germany, India, Italy, Japan, Jordan, Kuwait, Norway, Romania, South Korea, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom | 214 | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-06-12 | 1045254-2026-00822 | Malfunction | Available | exact di |
| 2026-06-01 | 1045254-2026-00764 | Malfunction | Available | exact di |
| 2026-05-14 | 1045254-2026-00678 | Malfunction | Available | exact di |
| 2026-05-14 | 1045254-2026-00679 | Malfunction | Available | exact di |
| 2026-04-17 | 1045254-2026-00539 | Malfunction | Available | exact di |
| 2026-04-13 | 1045254-2026-00514 | Malfunction | Available | exact di |
| 2026-04-10 | 1045254-2026-00499 | Malfunction | Available | exact di |
| 2026-04-08 | 1045254-2026-00486 | Malfunction | Available | exact di |
| 2026-04-07 | 1045254-2026-00478 | Malfunction | Available | exact di |
| 2026-04-03 | 1045254-2026-00448 | Malfunction | Available | exact di |
| 2026-03-23 | 1045254-2026-00387 | Malfunction | Available | exact di |
| 2026-03-20 | 1045254-2026-00379 | Malfunction | Available | exact di |
| 2026-03-17 | 1045254-2026-00359 | Malfunction | Available | exact di |
| 2026-03-11 | 1045254-2026-00323 | Malfunction | Available | exact di |
| 2026-03-09 | 1045254-2026-00316 | Malfunction | Available | exact di |
Showing the most recent 198 of 200 linked reports.
Showing 1–15 of 198
Regulatory clearances
Predicate lineage
Cited as predicate by: K143019, K153442, K153463, K161210, K170679, K173338, K181111, K182121, K182436, K201407, K203291, K210637, K211596, K214011, K231184
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 |
|---|---|---|---|---|
| 2026-02-06 | NAI | No action indicated | Medtronic Sofamor Danek USA Inc | 0 |
| 2017-10-26 | NAI | No action indicated | Medtronic Sofamor Danek USA, Inc | 0 |
| 2015-11-03 | VAI | Voluntary action indicated | Medtronic Sofamor Danek USA Inc | 0 |
| 2015-10-23 | VAI | Voluntary action indicated | Medtronic Sofamor Danek USA Inc | 1 |
| 2014-03-11 | VAI | Voluntary action indicated | Medtronic Sofamor Danek USA Inc | 0 |
| 2013-07-15 | NAI | No action indicated | Medtronic Sofamor Danek USA, Inc | 0 |
| 2013-07-15 | NAI | No action indicated | Medtronic Sofamor Danek USA Inc | 0 |
| 2012-06-06 | VAI | Voluntary action indicated | Medtronic Sofamor Danek USA Inc | 0 |
| 2011-02-23 | NAI | No action indicated | Medtronic Sofamor Danek Usa Inc | 0 |
| 2010-08-06 | VAI | Voluntary action indicated | Medtronic Sofamor Danek USA Inc | 0 |
| 2010-03-04 | VAI | Voluntary action indicated | Medtronic Sofamor Danek USA Inc | 0 |
| 2010-02-25 | NAI | No action indicated | Medtronic Sofamor Danek USA Inc | 0 |
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