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.
11 linked reportsMalfunction 10Injury 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.97 |
| 2019-02 | 0 | 4.45 |
| 2019-03 | 0 | 3.6 |
| 2019-04 | 0 | 3.18 |
| 2019-05 | 0 | 3.94 |
| 2019-06 | 0 | 3.31 |
| 2019-07 | 0 | 3.93 |
| 2019-08 | 0 | 4.29 |
| 2019-09 | 0 | 3.48 |
| 2019-10 | 0 | 4.12 |
| 2019-11 | 0 | 5.93 |
| 2019-12 | 0 | 4.32 |
| 2020-01 | 0 | 3.49 |
| 2020-02 | 0 | 5.16 |
| 2020-03 | 0 | 5.07 |
| 2020-04 | 0 | 8.75 |
| 2020-05 | 0 | 3.12 |
| 2020-06 | 0 | 3.41 |
| 2020-07 | 0 | 3.89 |
| 2020-08 | 0 | 2.74 |
| 2020-09 | 0 | 3.53 |
| 2020-10 | 0 | 5.36 |
| 2020-11 | 0 | 5.25 |
| 2020-12 | 0 | 4.21 |
| 2021-01 | 0 | 4.44 |
| 2021-02 | 0 | 3.93 |
| 2021-03 | 0 | 3.77 |
| 2021-04 | 0 | 3.78 |
| 2021-05 | 0 | 4.14 |
| 2021-06 | 0 | 3.67 |
| 2021-07 | 0 | 3.44 |
| 2021-08 | 0 | 3.19 |
| 2021-09 | 0 | 2.86 |
| 2021-10 | 0 | 2.49 |
| 2021-11 | 0 | 4.1 |
| 2021-12 | 0 | 2.91 |
| 2022-01 | 0 | 2.63 |
| 2022-02 | 1 | 3.08 |
| 2022-03 | 0 | 3.38 |
| 2022-04 | 0 | 2.42 |
| 2022-05 | 0 | 3.69 |
| 2022-06 | 0 | 4.19 |
| 2022-07 | 0 | 3.23 |
| 2022-08 | 0 | 2.87 |
| 2022-09 | 0 | 2.38 |
| 2022-10 | 1 | 3.7 |
| 2022-11 | 0 | 3.21 |
| 2022-12 | 0 | 3.77 |
| 2023-01 | 0 | 3 |
| 2023-02 | 0 | 3.25 |
| 2023-03 | 0 | 3.54 |
| 2023-04 | 0 | 2.97 |
| 2023-05 | 0 | 2.69 |
| 2023-06 | 0 | 2.64 |
| 2023-07 | 0 | 2.7 |
| 2023-08 | 0 | 2.45 |
| 2023-09 | 0 | 3.51 |
| 2023-10 | 0 | 3.27 |
| 2023-11 | 0 | 7.38 |
| 2023-12 | 1 | 3.52 |
| 2024-01 | 0 | 3.38 |
| 2024-02 | 0 | 3.89 |
| 2024-03 | 0 | 3.91 |
| 2024-04 | 0 | 4.13 |
| 2024-05 | 0 | 4.2 |
| 2024-06 | 0 | 3.92 |
| 2024-07 | 0 | 3.73 |
| 2024-08 | 0 | 4.32 |
| 2024-09 | 0 | 4.28 |
| 2024-10 | 0 | 5.72 |
| 2024-11 | 0 | 4.47 |
| 2024-12 | 0 | 3.73 |
| 2025-01 | 1 | 8.02 |
| 2025-02 | 2 | 4.63 |
| 2025-03 | 0 | 3.38 |
| 2025-04 | 1 | 3.86 |
| 2025-05 | 1 | 4.05 |
| 2025-06 | 0 | 3.87 |
| 2025-07 | 2 | 4 |
| 2025-08 | 0 | 4.85 |
| 2025-09 | 0 | 3.61 |
| 2025-10 | 0 | 5.35 |
| 2025-11 | 0 | 3.9 |
| 2025-12 | 0 | 5.05 |
| 2026-01 | 1 | 5.21 |
| 2026-02 | 0 | 4.28 |
| 2026-03 | 0 | 7.08 |
| 2026-04 | 0 | 6.17 |
| 2026-05 | 0 | 8.19 |
| 2026-06 | 0 | 5.1 |
Failure-mode summaryAI-generated
11 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2025-12-10 | Z-1122-2026 | Class II | Open, Classified | Software errors that can result in incorrect surgical instrument positioning during spinal surgery.Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Brazil, Canada, Canary Islands, China, Croatia, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, United States, Vietnam. | 549 systems | code info di |
| 2024-07-17 | Z-3156-2024 | Class II | Open, Classified | Software anomalies which can result in two separate issues: A lagging screen display during a navigated procedure; or the potential for a mismatch between the navigated screw and the screw information presented on the screen.Distribution: US Nationwide distribution in PR. | 94 devices | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-01-30 | 3005075696-2026-00038 | Malfunction | Available | exact di |
| 2025-07-22 | 3005075696-2025-00314 | Malfunction | Available | exact di |
| 2025-07-02 | 3005075696-2025-00302 | Injury | Available | exact di |
| 2025-05-05 | 3005075696-2025-00264 | Malfunction | Available | exact di |
| 2025-04-21 | 3005075696-2025-00251 | Malfunction | Available | exact di |
| 2025-02-05 | 3005075696-2025-00137 | Malfunction | Available | exact di |
| 2025-02-05 | 3005075696-2025-00140 | Malfunction | Available | exact di |
| 2025-01-28 | 3005075696-2025-00095 | Malfunction | Available | exact di |
| 2023-12-22 | 3005075696-2023-00066 | Malfunction | Available | exact di |
| 2022-10-19 | 3005075696-2022-00074 | Malfunction | Available | exact di |
| 2022-02-18 | 3005075696-2022-00010 | Malfunction | Available | exact di |
Regulatory clearances
- 510(k)K200935Substantially equivalent (SESE) · 2020-05-08clearance family
Predicate lineage
- K200935
Cited as predicate by: K203005
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
None in the loaded window.
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