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.
56 linked reportsInjury 46Malfunction 10
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 4.67 |
| 2019-02 | 0 | 2.34 |
| 2019-03 | 0 | 3.13 |
| 2019-04 | 2 | 3.17 |
| 2019-05 | 0 | 3.26 |
| 2019-06 | 4 | 2.82 |
| 2019-07 | 0 | 3.81 |
| 2019-08 | 2 | 3.49 |
| 2019-09 | 0 | 3.35 |
| 2019-10 | 0 | 3.19 |
| 2019-11 | 0 | 5.28 |
| 2019-12 | 0 | 5.45 |
| 2020-01 | 0 | 5.46 |
| 2020-02 | 0 | 4.5 |
| 2020-03 | 0 | 3.98 |
| 2020-04 | 0 | 5.42 |
| 2020-05 | 0 | 3.88 |
| 2020-06 | 0 | 3.71 |
| 2020-07 | 3 | 3.74 |
| 2020-08 | 0 | 4.23 |
| 2020-09 | 0 | 4.05 |
| 2020-10 | 0 | 4.53 |
| 2020-11 | 0 | 6.39 |
| 2020-12 | 0 | 5.41 |
| 2021-01 | 0 | 4.74 |
| 2021-02 | 9 | 3.95 |
| 2021-03 | 6 | 3.83 |
| 2021-04 | 0 | 3.82 |
| 2021-05 | 3 | 4.06 |
| 2021-06 | 0 | 4.11 |
| 2021-07 | 0 | 4 |
| 2021-08 | 0 | 4.46 |
| 2021-09 | 3 | 4.05 |
| 2021-10 | 0 | 4.44 |
| 2021-11 | 0 | 4.37 |
| 2021-12 | 0 | 4.43 |
| 2022-01 | 0 | 4 |
| 2022-02 | 0 | 3.37 |
| 2022-03 | 3 | 3.88 |
| 2022-04 | 0 | 3.8 |
| 2022-05 | 0 | 4.06 |
| 2022-06 | 0 | 3.85 |
| 2022-07 | 0 | 3.56 |
| 2022-08 | 12 | 4.39 |
| 2022-09 | 0 | 3.86 |
| 2022-10 | 0 | 4.15 |
| 2022-11 | 0 | 2.87 |
| 2022-12 | 0 | 3.93 |
| 2023-01 | 0 | 3.27 |
| 2023-02 | 3 | 3.2 |
| 2023-03 | 0 | 3.8 |
| 2023-04 | 0 | 4.26 |
| 2023-05 | 0 | 4.67 |
| 2023-06 | 0 | 4.2 |
| 2023-07 | 0 | 3.85 |
| 2023-08 | 0 | 4.49 |
| 2023-09 | 0 | 4.47 |
| 2023-10 | 0 | 4.71 |
| 2023-11 | 0 | 4.63 |
| 2023-12 | 0 | 5.49 |
| 2024-01 | 0 | 5.56 |
| 2024-02 | 0 | 4.93 |
| 2024-03 | 2 | 4.78 |
| 2024-04 | 0 | 5.43 |
| 2024-05 | 0 | 6.48 |
| 2024-06 | 0 | 7.52 |
| 2024-07 | 0 | 4.11 |
| 2024-08 | 0 | 4.21 |
| 2024-09 | 0 | 5 |
| 2024-10 | 0 | 4.7 |
| 2024-11 | 0 | 4.41 |
| 2024-12 | 0 | 4.25 |
| 2025-01 | 0 | 5.12 |
| 2025-02 | 0 | 4.81 |
| 2025-03 | 0 | 4.57 |
| 2025-04 | 0 | 4.98 |
| 2025-05 | 0 | 5.81 |
| 2025-06 | 0 | 5.47 |
| 2025-07 | 0 | 5.19 |
| 2025-08 | 0 | 5.08 |
| 2025-09 | 0 | 4.29 |
| 2025-10 | 0 | 4.62 |
| 2025-11 | 0 | 5.25 |
| 2025-12 | 0 | 6.07 |
| 2026-01 | 0 | 5.06 |
| 2026-02 | 0 | 5.39 |
| 2026-03 | 0 | 5.98 |
| 2026-04 | 0 | 5.93 |
| 2026-05 | 4 | 5.88 |
| 2026-06 | 0 | 6.16 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2024-10-29 | Z-0581-2025 | Class II | Open, Classified | Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.Distribution: Worldwide - US Nationwide distribution in the states of AK, AL, IL, IN, KY, MD, MN, NC, NE, NH, NJ, TX and the countries of CA, CL, CN, EC, ES, GB, KZ, NO, PE, PL, RU, TR. | 2,156 units | clearance family |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-05-11 | 1219602-2026-01372 | Malfunction | Available | catalog number |
| 2026-05-11 | 1219602-2026-01391 | Malfunction | Available | catalog number |
| 2024-03-14 | 1219602-2024-00508 | Malfunction | Available | catalog number |
| 2023-02-06 | 1219602-2023-00148 | Injury | Available | catalog number |
| 2022-08-04 | 1219602-2022-01099 | Injury | Available | catalog number |
| 2022-08-04 | 1219602-2022-01100 | Injury | Available | catalog number |
| 2022-08-04 | 1219602-2022-01098 | Injury | Available | catalog number |
| 2022-08-04 | 1219602-2022-01097 | Injury | Available | catalog number |
| 2022-03-09 | 1219602-2022-00340 | Injury | Available | catalog number |
| 2021-09-16 | 1219602-2021-02036 | Injury | Available | catalog number |
| 2021-05-07 | 1219602-2021-01062 | Injury | Available | catalog number |
| 2021-03-22 | 1219602-2021-00590 | Injury | Available | catalog number |
| 2021-03-18 | 1219602-2021-00557 | Injury | Available | catalog number |
| 2021-02-11 | 1219602-2021-00308 | Injury | Available | catalog number |
| 2021-02-11 | 1219602-2021-00310 | Injury | Available | catalog number |
Showing the most recent 21 of 56 linked reports.
Showing 1–15 of 21
Regulatory clearances
Predicate lineage
K071586
Cited as predicate by: K102660, K103262, K110473, K110773, K121018, K131325, K131769, K132912, K151105, K153395, K181746, K193558, K231376, K233730
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 |
|---|---|---|---|---|
| 2025-01-27 | NAI | No action indicated | Integrity Orthopaedics Inc | 0 |
| 2023-05-03 | NAI | No action indicated | CARTIHEAL, LTD | 0 |
| 2021-12-09 | VAI | Voluntary action indicated | Smith & Nephew, Inc. | 1 |
| 2021-12-09 | VAI | Voluntary action indicated | Smith & Nephew, Inc. | 1 |
| 2021-10-26 | NAI | No action indicated | Smith & Nephew Inc. | 0 |
| 2021-10-26 | NAI | No action indicated | Smith & Nephew Inc. | 0 |
| 2020-02-06 | VAI | Voluntary action indicated | Blue Belt Technologies, Inc | 6 |
| 2019-10-25 | NAI | No action indicated | Tusker Medical, Inc. | 0 |
| 2019-10-08 | VAI | Voluntary action indicated | Tusker Medical, Inc. | 3 |
| 2018-03-30 | NAI | No action indicated | Ascension Orthopedics, Inc | 0 |
| 2018-02-02 | NAI | No action indicated | Smith & Nephew, Inc. | 0 |
| 2018-02-02 | NAI | No action indicated | Smith & Nephew, Inc. | 0 |
| 2018-01-30 | NAI | No action indicated | Smith & Nephew | 0 |
| 2017-08-21 | NAI | No action indicated | Smith & Nephew, Inc. Advanced Surgical Devices Division | 0 |
| 2017-08-02 | VAI | Voluntary action indicated | Smith & Nephew, Inc. | 3 |
| 2017-08-02 | VAI | Voluntary action indicated | Smith & Nephew, Inc. | 3 |
| 2017-07-24 | NAI | No action indicated | Smith & Nephew, Inc. | 0 |
| 2017-07-24 | NAI | No action indicated | Smith & Nephew, Inc. | 0 |
| 2017-05-25 | NAI | No action indicated | Smith & Nephew, Inc. | 0 |
| 2017-05-25 | NAI | No action indicated | Smith & Nephew, Inc. | 0 |
| 2015-04-30 | WL | Warning Letter | Smith & Nephew Inc. | — |
| 2015-04-30 | WL | Warning Letter | Smith & Nephew Inc. | — |
| 2014-06-11 | WL | Warning Letter | Smith & Nephew, Inc. | — |
| 2010-09-16 | WL | Warning Letter | Ascension Orthopedics, Inc | — |
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