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.
26 linked reportsMalfunction 20Injury 6
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.13 |
| 2019-02 | 0 | 1.87 |
| 2019-03 | 0 | 1.91 |
| 2019-04 | 0 | 1.98 |
| 2019-05 | 0 | 2.19 |
| 2019-06 | 1 | 2.19 |
| 2019-07 | 1 | 1.63 |
| 2019-08 | 0 | 2.5 |
| 2019-09 | 0 | 1.79 |
| 2019-10 | 0 | 1.85 |
| 2019-11 | 0 | 2.12 |
| 2019-12 | 0 | 1.54 |
| 2020-01 | 0 | 2.35 |
| 2020-02 | 0 | 2.32 |
| 2020-03 | 0 | 2.33 |
| 2020-04 | 1 | 1.45 |
| 2020-05 | 0 | 2.16 |
| 2020-06 | 0 | 1.93 |
| 2020-07 | 1 | 1.72 |
| 2020-08 | 0 | 1.83 |
| 2020-09 | 0 | 2.09 |
| 2020-10 | 0 | 2.38 |
| 2020-11 | 0 | 2.23 |
| 2020-12 | 0 | 2.07 |
| 2021-01 | 0 | 2.1 |
| 2021-02 | 0 | 1.83 |
| 2021-03 | 0 | 2.2 |
| 2021-04 | 0 | 2.05 |
| 2021-05 | 0 | 1.96 |
| 2021-06 | 0 | 1.88 |
| 2021-07 | 0 | 6.91 |
| 2021-08 | 0 | 1.89 |
| 2021-09 | 0 | 1.69 |
| 2021-10 | 0 | 2.28 |
| 2021-11 | 1 | 1.97 |
| 2021-12 | 0 | 1.97 |
| 2022-01 | 0 | 2.05 |
| 2022-02 | 0 | 1.91 |
| 2022-03 | 1 | 1.68 |
| 2022-04 | 0 | 1.78 |
| 2022-05 | 0 | 1.68 |
| 2022-06 | 0 | 1.95 |
| 2022-07 | 11 | 3.29 |
| 2022-08 | 1 | 1.88 |
| 2022-09 | 0 | 2.72 |
| 2022-10 | 0 | 1.43 |
| 2022-11 | 1 | 1.57 |
| 2022-12 | 0 | 1.94 |
| 2023-01 | 1 | 1.61 |
| 2023-02 | 0 | 1.78 |
| 2023-03 | 0 | 1.77 |
| 2023-04 | 0 | 2 |
| 2023-05 | 0 | 1.57 |
| 2023-06 | 0 | 1.64 |
| 2023-07 | 0 | 1.73 |
| 2023-08 | 0 | 1.34 |
| 2023-09 | 0 | 2.57 |
| 2023-10 | 0 | 2.44 |
| 2023-11 | 0 | 2.19 |
| 2023-12 | 0 | 1.63 |
| 2024-01 | 0 | 2.39 |
| 2024-02 | 0 | 2.14 |
| 2024-03 | 0 | 3.63 |
| 2024-04 | 0 | 1.73 |
| 2024-05 | 0 | 3.39 |
| 2024-06 | 0 | 2.23 |
| 2024-07 | 1 | 1.78 |
| 2024-08 | 0 | 1.79 |
| 2024-09 | 0 | 2.58 |
| 2024-10 | 1 | 2.27 |
| 2024-11 | 0 | 1.88 |
| 2024-12 | 0 | 1.76 |
| 2025-01 | 0 | 2.31 |
| 2025-02 | 0 | 2.45 |
| 2025-03 | 1 | 2.18 |
| 2025-04 | 0 | 2.25 |
| 2025-05 | 1 | 2.5 |
| 2025-06 | 0 | 2.29 |
| 2025-07 | 0 | 1.72 |
| 2025-08 | 0 | 1.96 |
| 2025-09 | 0 | 1.88 |
| 2025-10 | 0 | 1.93 |
| 2025-11 | 1 | 1.97 |
| 2025-12 | 0 | 2.27 |
| 2026-01 | 0 | 2.39 |
| 2026-02 | 1 | 2.4 |
| 2026-03 | 0 | 2.34 |
| 2026-04 | 0 | 1.83 |
| 2026-05 | 0 | 2.19 |
| 2026-06 | 0 | 4.25 |
Failure-mode summaryAI-generated
26 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2011-06-28 | Z-2877-2011 | Terminated | Screws are longer then size etched on the screw. | — | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-02-03 | 2647346-2026-00043 | Malfunction | Available | exact di |
| 2025-11-03 | 2647346-2025-00188 | Malfunction | Available | exact di |
| 2025-05-26 | 1030489-2025-02061 | Malfunction | Available | exact di |
| 2025-03-05 | 1030489-2025-01165 | Injury | Available | exact di |
| 2024-10-03 | 1030489-2024-01224 | Injury | Available | exact di |
| 2024-07-11 | 1030489-2024-00810 | Injury | Available | exact di |
| 2023-01-10 | 1030489-2023-00019 | Malfunction | Available | exact di |
| 2022-11-01 | 1030489-2022-01000 | Malfunction | Available | exact di |
| 2022-08-04 | 1030489-2022-00733 | Malfunction | Available | exact di |
| 2022-07-27 | 1030489-2022-00698 | Malfunction | Available | exact di |
| 2022-07-27 | 1030489-2022-00696 | Malfunction | Available | exact di |
| 2022-07-26 | 1030489-2022-00687 | Malfunction | Available | exact di |
| 2022-07-21 | 1030489-2022-00680 | Malfunction | Available | exact di |
| 2022-07-21 | 1030489-2022-00679 | Malfunction | Available | exact di |
| 2022-07-20 | 1030489-2022-00671 | Malfunction | Available | exact di |
Showing 1–15 of 26
Regulatory clearances
Predicate lineage
K042498
Cited as predicate by: K152338
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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