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.
1 linked reportInjury 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.82 |
| 2019-02 | 0 | 2.4 |
| 2019-03 | 0 | 2.66 |
| 2019-04 | 0 | 2.55 |
| 2019-05 | 0 | 2.06 |
| 2019-06 | 0 | 1.78 |
| 2019-07 | 0 | 1.8 |
| 2019-08 | 0 | 2.04 |
| 2019-09 | 0 | 2.18 |
| 2019-10 | 0 | 2.36 |
| 2019-11 | 0 | 2 |
| 2019-12 | 0 | 2.33 |
| 2020-01 | 0 | 2.72 |
| 2020-02 | 0 | 2.43 |
| 2020-03 | 0 | 3.05 |
| 2020-04 | 0 | 2.15 |
| 2020-05 | 0 | 2.21 |
| 2020-06 | 1 | 1.92 |
| 2020-07 | 0 | 2.44 |
| 2020-08 | 0 | 1.97 |
| 2020-09 | 0 | 2.43 |
| 2020-10 | 0 | 2.48 |
| 2020-11 | 0 | 2.2 |
| 2020-12 | 0 | 2.25 |
| 2021-01 | 0 | 2.31 |
| 2021-02 | 0 | 2.02 |
| 2021-03 | 0 | 2.01 |
| 2021-04 | 0 | 1.94 |
| 2021-05 | 0 | 2.01 |
| 2021-06 | 0 | 2.33 |
| 2021-07 | 0 | 2.29 |
| 2021-08 | 0 | 2.14 |
| 2021-09 | 0 | 2.35 |
| 2021-10 | 0 | 2.17 |
| 2021-11 | 0 | 2.03 |
| 2021-12 | 0 | 2.24 |
| 2022-01 | 0 | 2.01 |
| 2022-02 | 0 | 2.17 |
| 2022-03 | 0 | 2.05 |
| 2022-04 | 0 | 2.12 |
| 2022-05 | 0 | 2.12 |
| 2022-06 | 0 | 2.08 |
| 2022-07 | 0 | 2.04 |
| 2022-08 | 0 | 2.07 |
| 2022-09 | 0 | 2.11 |
| 2022-10 | 0 | 2.08 |
| 2022-11 | 0 | 2.19 |
| 2022-12 | 0 | 2.14 |
| 2023-01 | 0 | 2.11 |
| 2023-02 | 0 | 1.99 |
| 2023-03 | 0 | 2.14 |
| 2023-04 | 0 | 2.11 |
| 2023-05 | 0 | 2.09 |
| 2023-06 | 0 | 2.14 |
| 2023-07 | 0 | 2.06 |
| 2023-08 | 0 | 1.9 |
| 2023-09 | 0 | 1.91 |
| 2023-10 | 0 | 1.59 |
| 2023-11 | 0 | 1.6 |
| 2023-12 | 0 | 1.67 |
| 2024-01 | 0 | 1.68 |
| 2024-02 | 0 | 1.96 |
| 2024-03 | 0 | 1.89 |
| 2024-04 | 0 | 1.71 |
| 2024-05 | 0 | 2.04 |
| 2024-06 | 0 | 1.84 |
| 2024-07 | 0 | 1.69 |
| 2024-08 | 0 | 1.83 |
| 2024-09 | 0 | 1.88 |
| 2024-10 | 0 | 1.68 |
| 2024-11 | 0 | 1.69 |
| 2024-12 | 0 | 1.54 |
| 2025-01 | 0 | 1.84 |
| 2025-02 | 0 | 1.49 |
| 2025-03 | 0 | 1.73 |
| 2025-04 | 0 | 1.79 |
| 2025-05 | 0 | 1.66 |
| 2025-06 | 0 | 1.8 |
| 2025-07 | 0 | 1.77 |
| 2025-08 | 0 | 1.65 |
| 2025-09 | 0 | 1.68 |
| 2025-10 | 0 | 1.71 |
| 2025-11 | 0 | 1.79 |
| 2025-12 | 0 | 1.87 |
| 2026-01 | 0 | 1.96 |
| 2026-02 | 0 | 1.63 |
| 2026-03 | 0 | 1.93 |
| 2026-04 | 0 | 1.91 |
| 2026-05 | 0 | 1.75 |
| 2026-06 | 0 | 1.71 |
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2020-06-12 | 1020279-2020-02360 | Injury | Available | catalog number |
Regulatory clearances
Predicate lineage
Cited as predicate by: K211176
- K211176
- K002747
- K002996
- K021673
- K021803
- K022556
- K022902
- K022958
- K023302
- K023743
- K033442
- K040680
- K052792
- K070278
- K070756
- K071160
- K072817
- K072852
- K081124
- K083566
- K083762
- K092386
- K093363
- K093991
- K100412
- K100481
- K102370
- K103256
- K110101
- K110135
- K113848
- K120211
- K121627
- K122244
- K122296
- K123012
- K130728
- K143739
- K150790
- K151902
- K160923
- K162303
- K171073
- K171934
- K182109
- K182535
- K791125
- K823723
- K823727
- K831884
- K896580
- K900628
- K914878
- K920430
- K921400
- K932755
- K934353
- K960094
- K962541
- K963486
- K963509
- K970337
- K970351
- K971414
- K983834
- K990369
- K990666
- K991485
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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