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.
2 linked reportsInjury 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.87 |
| 2019-02 | 0 | 1.55 |
| 2019-03 | 0 | 1.78 |
| 2019-04 | 0 | 2.29 |
| 2019-05 | 0 | 1.63 |
| 2019-06 | 0 | 1.63 |
| 2019-07 | 0 | 1.79 |
| 2019-08 | 0 | 1.55 |
| 2019-09 | 0 | 1.61 |
| 2019-10 | 0 | 1.47 |
| 2019-11 | 0 | 1.68 |
| 2019-12 | 0 | 1.91 |
| 2020-01 | 0 | 2.08 |
| 2020-02 | 0 | 1.33 |
| 2020-03 | 0 | 1.59 |
| 2020-04 | 0 | 1.81 |
| 2020-05 | 0 | 1.66 |
| 2020-06 | 0 | 1.93 |
| 2020-07 | 0 | 1.85 |
| 2020-08 | 0 | 2.3 |
| 2020-09 | 0 | 2.68 |
| 2020-10 | 0 | 2.03 |
| 2020-11 | 0 | 2.17 |
| 2020-12 | 0 | 2.26 |
| 2021-01 | 0 | 1.75 |
| 2021-02 | 0 | 2.08 |
| 2021-03 | 0 | 2.23 |
| 2021-04 | 0 | 2.74 |
| 2021-05 | 0 | 2.69 |
| 2021-06 | 0 | 2.02 |
| 2021-07 | 2 | 2.13 |
| 2021-08 | 0 | 1.81 |
| 2021-09 | 0 | 2 |
| 2021-10 | 0 | 1.88 |
| 2021-11 | 0 | 2.26 |
| 2021-12 | 0 | 2.1 |
| 2022-01 | 0 | 2.68 |
| 2022-02 | 0 | 2.24 |
| 2022-03 | 0 | 1.76 |
| 2022-04 | 0 | 2.1 |
| 2022-05 | 0 | 2.24 |
| 2022-06 | 0 | 2.34 |
| 2022-07 | 0 | 2.23 |
| 2022-08 | 0 | 2.03 |
| 2022-09 | 0 | 2.42 |
| 2022-10 | 0 | 3 |
| 2022-11 | 0 | 3.07 |
| 2022-12 | 0 | 2.74 |
| 2023-01 | 0 | 2.59 |
| 2023-02 | 0 | 2.47 |
| 2023-03 | 0 | 2.78 |
| 2023-04 | 0 | 2.95 |
| 2023-05 | 0 | 3.91 |
| 2023-06 | 0 | 2.83 |
| 2023-07 | 0 | 2.21 |
| 2023-08 | 0 | 2.04 |
| 2023-09 | 0 | 2.12 |
| 2023-10 | 0 | 2.29 |
| 2023-11 | 0 | 1.92 |
| 2023-12 | 0 | 2.24 |
| 2024-01 | 0 | 1.95 |
| 2024-02 | 0 | 1.77 |
| 2024-03 | 0 | 1.73 |
| 2024-04 | 0 | 2.08 |
| 2024-05 | 0 | 1.85 |
| 2024-06 | 0 | 2.24 |
| 2024-07 | 0 | 2.07 |
| 2024-08 | 0 | 2.15 |
| 2024-09 | 0 | 1.6 |
| 2024-10 | 0 | 2.28 |
| 2024-11 | 0 | 1.62 |
| 2024-12 | 0 | 2.96 |
| 2025-01 | 0 | 1.58 |
| 2025-02 | 0 | 1.73 |
| 2025-03 | 0 | 2.55 |
| 2025-04 | 0 | 1.84 |
| 2025-05 | 0 | 2 |
| 2025-06 | 0 | 1.65 |
| 2025-07 | 0 | 2.05 |
| 2025-08 | 0 | 1.95 |
| 2025-09 | 0 | 1.71 |
| 2025-10 | 0 | 2.17 |
| 2025-11 | 0 | 1.91 |
| 2025-12 | 0 | 2.32 |
| 2026-01 | 0 | 1.67 |
| 2026-02 | 0 | 1.92 |
| 2026-03 | 0 | 2.8 |
| 2026-04 | 0 | 2.18 |
| 2026-05 | 0 | 2.2 |
| 2026-06 | 0 | 1.79 |
Failure-mode summaryAI-generated
2 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2021-10-29 | Z-0319-2022 | Class II | Open, Classified | The Instructions for Use have been updated to include: (1) Clarification that the device is intended for use only in patients 18 years and older, (2) That patients should weigh 50 lbs. or more while undergoing treatment, and (3) That no more than two devices should be implanted at a time.Distribution: U.S.: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, TN, TX, UT, VA, WA, WI, and WV. O.U.S.: Argentina, Australia, Austria, Belgium, Canada, Colombia, Chile, Cyprus, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Jordan, Luxemburg, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey, UAE, United Kingdom. | Total 11,861 devices (IMLL=10,657 and Short=1,204) | code info di |
| 2021-02-12 | Z-1323-2021 | Class II | Open, Classified | Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.Distribution: Worldwide distribution - U.S. Nationwide distribution and the countries of Argentina, Austria, Belgium, Canada, Chile, Colombia, Cyprus, Denmark, Finland, France, Germany, Greece, Hong Kong, Israel, Italy, Luxemburg, Netherlands, Portugal, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey and UAE. Consignee List provided only includes email addresses. Complete contact information is pending. | 2360 units | code info di |
| 2021-02-12 | Z-1325-2021 | Class II | Open, Classified | Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments.Distribution: Worldwide distribution - U.S. Nationwide distribution and the countries of Argentina, Austria, Belgium, Canada, Chile, Colombia, Cyprus, Denmark, Finland, France, Germany, Greece, Hong Kong, Israel, Italy, Luxemburg, Netherlands, Portugal, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey and UAE. Consignee List provided only includes email addresses. Complete contact information is pending. | 40 units | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2021-07-07 | 3006179046-2021-00365 | Injury | Available | exact di |
Showing the most recent 1 of 2 linked reports.
Regulatory clearances
Predicate lineage
- K192181
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 |
|---|---|---|---|---|
| 2024-05-06 | VAI | Voluntary action indicated | NuVasive Specialized Orthopedics, Inc. | 12 |
| 2014-02-20 | NAI | No action indicated | NuVasive Specialized Orthopedics, Inc. | 0 |
Similar devices
- Locking Fibula Plate, 5 Holes FLOWER ORTHOPEDICS CORPORATION
- osteo-WEDGE 2.5mm x 08mm Locking Bone Screw Graham Medical Technologies, L.L.C.
- osteo-WEDGE 3.0mm x 16mm Locking Bone Screw Graham Medical Technologies, L.L.C.
- """2.0/2.4MM"" FRACTURE SYSTEM" BIOMET MICROFIXATION, INC
- "2.4mm Wise-Lock ""L'' Distal Radius Dorsal Plate, Oblique, Right, 3 holes" Auxein Medical Private Limited
- "2.4mm Wise-Lock ""L'' Distal Radius Dorsal Plate, Oblique, Right, 3 holes" Auxein Medical Private Limited
- "2.4mm Wise-Lock ""L'' Distal Radius Dorsal Plate, Oblique, Right, 4 holes" Auxein Medical Private Limited
- "2.4mm Wise-Lock ""L'' Distal Radius Dorsal Plate, Oblique, Right, 4 holes" Auxein Medical Private Limited
- "2.4mm Wise-Lock ""L'' Distal Radius Dorsal Plate, Oblique, left, 3 holes" Auxein Medical Private Limited
- "2.4mm Wise-Lock ""L'' Distal Radius Dorsal Plate, Oblique, left, 3 holes" Auxein Medical Private Limited
- "2.4mm Wise-Lock ""L'' Distal Radius Dorsal Plate, Oblique, left, 4 holes" Auxein Medical Private Limited
- "2.4mm Wise-Lock ""L'' Distal Radius Dorsal Plate, Oblique, left, 4 holes" Auxein Medical Private Limited
Select up to two to place side-by-side with this device.