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.
394 linked reportsMalfunction 337Injury 55Death 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 8.9 |
| 2019-02 | 0 | 9.8 |
| 2019-03 | 0 | 9.75 |
| 2019-04 | 0 | 11.69 |
| 2019-05 | 0 | 13.12 |
| 2019-06 | 2 | 12.96 |
| 2019-07 | 0 | 9.95 |
| 2019-08 | 0 | 7.99 |
| 2019-09 | 0 | 7.92 |
| 2019-10 | 0 | 7.3 |
| 2019-11 | 0 | 9.9 |
| 2019-12 | 0 | 10.2 |
| 2020-01 | 2 | 7.88 |
| 2020-02 | 2 | 9.2 |
| 2020-03 | 2 | 9.63 |
| 2020-04 | 3 | 9.82 |
| 2020-05 | 2 | 11.02 |
| 2020-06 | 4 | 8.31 |
| 2020-07 | 4 | 9.32 |
| 2020-08 | 0 | 8.15 |
| 2020-09 | 3 | 8.27 |
| 2020-10 | 5 | 9.59 |
| 2020-11 | 4 | 10.39 |
| 2020-12 | 3 | 8.93 |
| 2021-01 | 6 | 8.68 |
| 2021-02 | 3 | 9.35 |
| 2021-03 | 2 | 8.99 |
| 2021-04 | 7 | 8.52 |
| 2021-05 | 12 | 9.47 |
| 2021-06 | 6 | 10.69 |
| 2021-07 | 4 | 8.42 |
| 2021-08 | 6 | 9.77 |
| 2021-09 | 2 | 12.18 |
| 2021-10 | 6 | 7.93 |
| 2021-11 | 12 | 10.31 |
| 2021-12 | 4 | 7.26 |
| 2022-01 | 4 | 6.61 |
| 2022-02 | 4 | 7.31 |
| 2022-03 | 0 | 8.86 |
| 2022-04 | 3 | 6.09 |
| 2022-05 | 1 | 8.41 |
| 2022-06 | 3 | 8.93 |
| 2022-07 | 2 | 8.26 |
| 2022-08 | 3 | 8.34 |
| 2022-09 | 2 | 8.3 |
| 2022-10 | 6 | 10.94 |
| 2022-11 | 3 | 9.53 |
| 2022-12 | 3 | 9.44 |
| 2023-01 | 4 | 8.45 |
| 2023-02 | 2 | 7.9 |
| 2023-03 | 4 | 9.28 |
| 2023-04 | 4 | 9.15 |
| 2023-05 | 1 | 9.77 |
| 2023-06 | 0 | 11.43 |
| 2023-07 | 3 | 12.71 |
| 2023-08 | 0 | 12.41 |
| 2023-09 | 1 | 10.13 |
| 2023-10 | 3 | 10.28 |
| 2023-11 | 2 | 13.1 |
| 2023-12 | 7 | 10.93 |
| 2024-01 | 4 | 15.12 |
| 2024-02 | 6 | 11.44 |
| 2024-03 | 7 | 13.24 |
| 2024-04 | 6 | 12.3 |
| 2024-05 | 4 | 11.41 |
| 2024-06 | 3 | 10.73 |
| 2024-07 | 9 | 12.56 |
| 2024-08 | 3 | 17.28 |
| 2024-09 | 2 | 13.51 |
| 2024-10 | 3 | 16.9 |
| 2024-11 | 6 | 10.13 |
| 2024-12 | 2 | 9.94 |
| 2025-01 | 46 | 11.72 |
| 2025-02 | 39 | 13.25 |
| 2025-03 | 3 | 11.17 |
| 2025-04 | 1 | 12.54 |
| 2025-05 | 4 | 11.8 |
| 2025-06 | 7 | 14.78 |
| 2025-07 | 2 | 11.03 |
| 2025-08 | 5 | 9.86 |
| 2025-09 | 0 | 9.79 |
| 2025-10 | 3 | 10.5 |
| 2025-11 | 6 | 8.59 |
| 2025-12 | 22 | 8.49 |
| 2026-01 | 20 | 9.73 |
| 2026-02 | 6 | 7.66 |
| 2026-03 | 2 | 10.03 |
| 2026-04 | 1 | 8.18 |
| 2026-05 | 1 | 9.32 |
| 2026-06 | 0 | 6.38 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2025-12-10 | 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 |
| 2023-09-05 | Z-0101-2024 | Class II | Open, Classified | Software updateDistribution: US Nationwide distribution. | 324 devices | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-05-27 | 3005075696-2026-00102 | Malfunction | Available | exact di |
| 2026-04-10 | 3005075696-2026-00085 | Injury | Available | exact di |
| 2026-03-30 | 3005075696-2026-00076 | Malfunction | Available | exact di |
| 2026-03-20 | 3005075696-2026-00073 | Malfunction | Available | exact di |
| 2026-02-27 | 3005075696-2026-00065 | Injury | Available | exact di |
| 2026-02-27 | 3005075696-2026-00063 | Malfunction | Available | exact di |
| 2026-02-23 | 3005075696-2026-00055 | Malfunction | Available | exact di |
| 2026-02-23 | 3005075696-2026-00054 | Malfunction | Available | exact di |
| 2026-02-13 | 3005075696-2026-00050 | Injury | Available | exact di |
| 2026-02-05 | 3005075696-2026-00045 | Malfunction | Available | exact di |
| 2026-01-26 | 3005075696-2026-00031 | Malfunction | Available | exact di |
| 2026-01-07 | 3005075696-2026-00022 | Malfunction | Available | exact di |
| 2026-01-01 | 3005075696-2026-00013 | Malfunction | Available | exact di |
| 2026-01-01 | 3005075696-2026-00011 | Malfunction | Available | exact di |
| 2026-01-01 | 3005075696-2026-00007 | Malfunction | Available | exact di |
Showing the most recent 200 of 394 linked reports.
Showing 1–15 of 200
Regulatory clearances
None linked.
Manufacturer compliance record
None in the loaded window.
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