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.
31 linked reportsMalfunction 31
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 1 | 3.54 |
| 2019-02 | 0 | 1.87 |
| 2019-03 | 0 | 2.04 |
| 2019-04 | 0 | 2.45 |
| 2019-05 | 0 | 2.22 |
| 2019-06 | 0 | 2.15 |
| 2019-07 | 0 | 2.45 |
| 2019-08 | 0 | 2.4 |
| 2019-09 | 0 | 2.54 |
| 2019-10 | 0 | 2.34 |
| 2019-11 | 0 | 3.11 |
| 2019-12 | 0 | 3.28 |
| 2020-01 | 0 | 3.2 |
| 2020-02 | 0 | 2.57 |
| 2020-03 | 0 | 2.65 |
| 2020-04 | 0 | 3.16 |
| 2020-05 | 0 | 2.36 |
| 2020-06 | 0 | 2.68 |
| 2020-07 | 0 | 2.88 |
| 2020-08 | 0 | 3.06 |
| 2020-09 | 0 | 2.84 |
| 2020-10 | 0 | 3.01 |
| 2020-11 | 0 | 4 |
| 2020-12 | 0 | 3.65 |
| 2021-01 | 0 | 2.77 |
| 2021-02 | 0 | 2.94 |
| 2021-03 | 0 | 3.06 |
| 2021-04 | 0 | 3.16 |
| 2021-05 | 0 | 3.13 |
| 2021-06 | 1 | 2.88 |
| 2021-07 | 0 | 2.82 |
| 2021-08 | 0 | 2.84 |
| 2021-09 | 0 | 3.14 |
| 2021-10 | 0 | 3.16 |
| 2021-11 | 0 | 3.13 |
| 2021-12 | 0 | 3.24 |
| 2022-01 | 0 | 3.6 |
| 2022-02 | 0 | 2.76 |
| 2022-03 | 0 | 2.94 |
| 2022-04 | 0 | 2.69 |
| 2022-05 | 0 | 2.91 |
| 2022-06 | 0 | 2.81 |
| 2022-07 | 0 | 2.76 |
| 2022-08 | 0 | 3.25 |
| 2022-09 | 0 | 3.21 |
| 2022-10 | 5 | 3.57 |
| 2022-11 | 0 | 2.8 |
| 2022-12 | 0 | 4.31 |
| 2023-01 | 1 | 3.23 |
| 2023-02 | 0 | 2.94 |
| 2023-03 | 0 | 3.37 |
| 2023-04 | 2 | 3.35 |
| 2023-05 | 4 | 3.73 |
| 2023-06 | 0 | 3.66 |
| 2023-07 | 1 | 2.95 |
| 2023-08 | 1 | 3.16 |
| 2023-09 | 0 | 3.27 |
| 2023-10 | 0 | 3.21 |
| 2023-11 | 1 | 3.24 |
| 2023-12 | 0 | 3.89 |
| 2024-01 | 4 | 4.03 |
| 2024-02 | 1 | 3.06 |
| 2024-03 | 3 | 3.52 |
| 2024-04 | 1 | 3.49 |
| 2024-05 | 1 | 4.03 |
| 2024-06 | 0 | 4.49 |
| 2024-07 | 0 | 3.24 |
| 2024-08 | 0 | 3.03 |
| 2024-09 | 0 | 3.49 |
| 2024-10 | 0 | 3.47 |
| 2024-11 | 0 | 3.32 |
| 2024-12 | 0 | 3.68 |
| 2025-01 | 0 | 3.9 |
| 2025-02 | 0 | 3.43 |
| 2025-03 | 1 | 3.36 |
| 2025-04 | 0 | 3.68 |
| 2025-05 | 1 | 3.91 |
| 2025-06 | 0 | 3.73 |
| 2025-07 | 2 | 3.7 |
| 2025-08 | 0 | 3.75 |
| 2025-09 | 0 | 3.46 |
| 2025-10 | 0 | 3.78 |
| 2025-11 | 0 | 3.85 |
| 2025-12 | 0 | 4.64 |
| 2026-01 | 0 | 4.1 |
| 2026-02 | 0 | 4.3 |
| 2026-03 | 0 | 4.3 |
| 2026-04 | 0 | 4.13 |
| 2026-05 | 0 | 4.85 |
| 2026-06 | 0 | 4.54 |
Failure-mode summaryAI-generated
31 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-07-30 | 1221934-2025-02860 | Malfunction | Available | exact di |
| 2025-07-25 | 1221934-2025-02772 | Malfunction | Available | exact di |
| 2025-05-08 | 1221934-2025-01698 | Malfunction | Available | exact di |
| 2025-03-19 | 1221934-2025-00984 | Malfunction | Available | exact di |
| 2024-05-22 | 1221934-2024-01660 | Malfunction | Available | exact di |
| 2024-04-25 | 1221934-2024-01341 | Malfunction | Available | exact di |
| 2024-03-14 | 1221934-2024-00846 | Malfunction | Available | exact di |
| 2024-03-14 | 1221934-2024-00845 | Malfunction | Available | exact di |
| 2024-03-07 | 1221934-2024-00780 | Malfunction | Available | exact di |
| 2024-02-08 | 1221934-2024-00406 | Malfunction | Available | exact di |
| 2024-01-18 | 1221934-2024-00163 | Malfunction | Available | catalog number |
| 2024-01-18 | 1221934-2024-00162 | Malfunction | Available | catalog number |
| 2023-11-09 | 1221934-2023-04075 | Malfunction | Available | exact di |
| 2023-08-29 | 1221934-2023-03215 | Malfunction | Available | exact di |
| 2023-07-28 | 1221934-2023-02844 | Malfunction | Available | exact di |
Showing the most recent 29 of 31 linked reports.
Showing 1–15 of 29
Regulatory clearances
- 510(k)K103712Substantially equivalent (SESE) · 2011-03-11clearance family
Predicate lineage
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
- 3.3mm Screw Fastener Self Tapping 14mm Osteocentric Technologies, Inc.
- 3.3mm Screw Fastener Self Tapping 16mm Osteocentric Technologies, Inc.
- 3.3mm Screw Fastener Self Tapping 18mm Osteocentric Technologies, Inc.
- 3.3mm Screw Fastener Self Tapping 20mm Osteocentric Technologies, Inc.
- 4.0 x 22mm LOCKING BONE SCREW FASTENER ST Osteocentric Technologies, Inc.
- Biosteon® IntraLine® BIOCOMPOSITES LTD
- CORTICAL BONE SCREW 3.5mm x 16mm ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- CORTICAL BONE SCREW 3.5mm x 20mm ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- CORTICAL BONE SCREW 3.5mm x 24mm ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- CORTICAL BONE SCREW 3.5mm x 26mm ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
- Container FOURNITURES HOSPITALIERES INDUSTRIE
- Pin guide cannula FOURNITURES HOSPITALIERES INDUSTRIE
Select up to two to place side-by-side with this device.