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.
112 linked reportsMalfunction 97Injury 15
| 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 | 1 | 4.14 |
| 2021-06 | 0 | 3.67 |
| 2021-07 | 0 | 3.44 |
| 2021-08 | 1 | 3.19 |
| 2021-09 | 0 | 2.86 |
| 2021-10 | 1 | 2.49 |
| 2021-11 | 0 | 4.1 |
| 2021-12 | 0 | 2.91 |
| 2022-01 | 0 | 2.63 |
| 2022-02 | 3 | 3.08 |
| 2022-03 | 2 | 3.38 |
| 2022-04 | 2 | 2.42 |
| 2022-05 | 1 | 3.69 |
| 2022-06 | 1 | 4.19 |
| 2022-07 | 2 | 3.23 |
| 2022-08 | 1 | 2.87 |
| 2022-09 | 3 | 2.38 |
| 2022-10 | 0 | 3.7 |
| 2022-11 | 0 | 3.21 |
| 2022-12 | 0 | 3.77 |
| 2023-01 | 1 | 3 |
| 2023-02 | 0 | 3.25 |
| 2023-03 | 0 | 3.54 |
| 2023-04 | 2 | 2.97 |
| 2023-05 | 2 | 2.69 |
| 2023-06 | 1 | 2.64 |
| 2023-07 | 0 | 2.7 |
| 2023-08 | 0 | 2.45 |
| 2023-09 | 0 | 3.51 |
| 2023-10 | 0 | 3.27 |
| 2023-11 | 2 | 7.38 |
| 2023-12 | 0 | 3.52 |
| 2024-01 | 1 | 3.38 |
| 2024-02 | 2 | 3.89 |
| 2024-03 | 1 | 3.91 |
| 2024-04 | 3 | 4.13 |
| 2024-05 | 1 | 4.2 |
| 2024-06 | 1 | 3.92 |
| 2024-07 | 0 | 3.73 |
| 2024-08 | 7 | 4.32 |
| 2024-09 | 3 | 4.28 |
| 2024-10 | 1 | 5.72 |
| 2024-11 | 2 | 4.47 |
| 2024-12 | 2 | 3.73 |
| 2025-01 | 23 | 8.02 |
| 2025-02 | 15 | 4.63 |
| 2025-03 | 1 | 3.38 |
| 2025-04 | 2 | 3.86 |
| 2025-05 | 2 | 4.05 |
| 2025-06 | 1 | 3.87 |
| 2025-07 | 2 | 4 |
| 2025-08 | 3 | 4.85 |
| 2025-09 | 1 | 3.61 |
| 2025-10 | 1 | 5.35 |
| 2025-11 | 1 | 3.9 |
| 2025-12 | 4 | 5.05 |
| 2026-01 | 1 | 5.21 |
| 2026-02 | 2 | 4.28 |
| 2026-03 | 2 | 7.08 |
| 2026-04 | 1 | 6.17 |
| 2026-05 | 0 | 8.19 |
| 2026-06 | 0 | 5.1 |
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 |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-04-06 | 3005075696-2026-00081 | Malfunction | Available | exact di |
| 2026-03-03 | 3005075696-2026-00067 | Malfunction | Available | exact di |
| 2026-03-02 | 3005075696-2026-00066 | Malfunction | Available | exact di |
| 2026-02-26 | 3005075696-2026-00061 | Injury | Available | exact di |
| 2026-02-10 | 3005075696-2026-00046 | Malfunction | Available | exact di |
| 2026-01-07 | 3005075696-2026-00023 | Malfunction | Available | exact di |
| 2025-12-26 | 3005075696-2025-00436 | Malfunction | Available | exact di |
| 2025-12-26 | 3005075696-2025-00434 | Malfunction | Available | exact di |
| 2025-12-19 | 3005075696-2025-00414 | Malfunction | Available | exact di |
| 2025-12-02 | 3005075696-2025-00397 | Malfunction | Available | exact di |
| 2025-11-18 | 3005075696-2025-00385 | Malfunction | Available | exact di |
| 2025-10-15 | 3005075696-2025-00366 | Malfunction | Available | exact di |
| 2025-09-18 | 3005075696-2025-00339 | Malfunction | Available | exact di |
| 2025-08-21 | 3005075696-2025-00330 | Malfunction | Available | exact di |
| 2025-08-11 | 3005075696-2025-00323 | Malfunction | Available | exact di |
Showing 1–15 of 112
Regulatory clearances
Predicate lineage
- 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.
Similar devices
- ENDSCP NAV INTERFACE (Ø 6,1 mm) MEDTECH
- ENDSCP NAV INTERFACE (Ø 6,7 mm) MEDTECH
- Paradigm Navigated Drill Guide Case Tray Proprio, Inc.
- "7D Surgical Ratcheting Handle, 1/4"" Square" 7D Surgical ULC
- "CI FEM&TIB CUT BLOCK ADP "" DEPUY PFC SP2""" Brainlab SE
- "icotec Systems, Handle, 1/4"" Coupling" icotec AG
- 063377717 Philips Ultrasound LLC
- 11-0052 7D Flex Rod Connector - ø5.5mm - 150mm 7D Surgical ULC
- 2-Pin Drill Template, X-Press Brainlab SE
- 2.0 mm Pin Repositioner, Even Si-Bone Inc.
- 2.0 mm Pin Repositioner, Odd Si-Bone Inc.
- 2.5 mm Pin Repositioner, Even Si-Bone Inc.
Select up to two to place side-by-side with this device.