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 reportMalfunction 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2 |
| 2019-03 | 0 | 1 |
| 2019-04 | 0 | 1.5 |
| 2019-05 | 0 | 1 |
| 2019-06 | 0 | 1 |
| 2019-08 | 0 | 1 |
| 2019-09 | 0 | 1 |
| 2020-01 | 0 | 3 |
| 2020-02 | 0 | 3 |
| 2020-03 | 0 | 4 |
| 2020-04 | 0 | 3 |
| 2020-05 | 0 | 2 |
| 2020-08 | 0 | 1 |
| 2020-10 | 0 | 1.5 |
| 2020-11 | 0 | 3 |
| 2020-12 | 0 | 2 |
| 2021-02 | 0 | 3 |
| 2021-03 | 0 | 1.33 |
| 2021-04 | 0 | 2 |
| 2021-05 | 0 | 5.5 |
| 2021-07 | 0 | 2 |
| 2021-08 | 0 | 2 |
| 2021-09 | 0 | 3 |
| 2021-10 | 0 | 2 |
| 2021-11 | 0 | 1.5 |
| 2021-12 | 0 | 2 |
| 2022-04 | 0 | 1.67 |
| 2022-06 | 0 | 1 |
| 2022-08 | 0 | 3.67 |
| 2022-09 | 0 | 2.5 |
| 2022-10 | 0 | 1 |
| 2022-11 | 0 | 2 |
| 2023-01 | 0 | 2 |
| 2023-02 | 0 | 1 |
| 2023-03 | 0 | 3 |
| 2023-04 | 0 | 3 |
| 2023-05 | 0 | 2.5 |
| 2023-06 | 0 | 3 |
| 2023-07 | 0 | 1 |
| 2023-08 | 0 | 1 |
| 2023-09 | 0 | 2 |
| 2023-10 | 0 | 2.5 |
| 2023-11 | 0 | 1.33 |
| 2023-12 | 0 | 1 |
| 2024-01 | 0 | 1 |
| 2024-02 | 0 | 4 |
| 2024-03 | 0 | 2 |
| 2024-04 | 0 | 2 |
| 2024-05 | 0 | 2 |
| 2024-06 | 0 | 1.5 |
| 2024-07 | 0 | 2 |
| 2024-09 | 1 | 1 |
| 2024-10 | 0 | 2.5 |
| 2024-11 | 0 | 1 |
| 2025-01 | 0 | 1.33 |
| 2025-02 | 0 | 2.83 |
| 2025-03 | 0 | 3.67 |
| 2025-04 | 0 | 2.67 |
| 2025-05 | 0 | 2.33 |
| 2025-06 | 0 | 1.8 |
| 2025-07 | 0 | 4 |
| 2025-08 | 0 | 3.33 |
| 2025-09 | 0 | 1.25 |
| 2025-10 | 0 | 1.33 |
| 2025-11 | 0 | 1.33 |
| 2025-12 | 0 | 2.56 |
| 2026-01 | 0 | 3.67 |
| 2026-02 | 0 | 2.71 |
| 2026-03 | 0 | 1.7 |
| 2026-04 | 0 | 4.6 |
| 2026-05 | 0 | 2.5 |
| 2026-06 | 0 | 1.5 |
Failure-mode summaryAI-generated
1 linked report narrative available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2025-02-06 | Z-1295-2025 | Class II | Open, Classified | Possibility for the obturator to break (separate).Distribution: US Nationwide distribution in the states of MO, FL, TX, NY, IL, OH, NJ, CA, MN, WA, TN, MD, LA, OK, SC, PA, MI, KY, NC, DC. | 623 units | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2024-09-13 | 3013505638-2024-00003 | Malfunction | Available | exact di |
Regulatory clearances
- 510(k)K250752Substantially equivalent (SESE) · 2025-04-09clearance family
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2025-09-17 | NAI | No action indicated | Integra LifeSciences Corporation | 0 |
| 2025-09-17 | NAI | No action indicated | Integra LifeSciences Corporation | 0 |
| 2025-06-06 | NAI | No action indicated | Integra LifeSciences Corporation | 0 |
| 2025-06-06 | NAI | No action indicated | Integra LifeSciences Corporation | 0 |
| 2025-02-12 | NAI | No action indicated | Surgical Innovation Associates Inc | 0 |
| 2024-12-19 | WL | Warning Letter | Integra LifeSciences Corporation | — |
| 2024-12-19 | WL | Warning Letter | Integra LifeSciences Corporation | — |
| 2024-08-22 | OAI | Official action indicated | Integra LifeSciences Corp. (NeuroSciences) | 0 |
| 2024-08-22 | OAI | Official action indicated | Integra LifeSciences Corporation | 0 |
| 2024-08-22 | OAI | Official action indicated | Integra LifeSciences Corporation | 0 |
| 2024-06-05 | OAI | Official action indicated | Integra LifeSciences Corporation | 7 |
| 2024-06-05 | OAI | Official action indicated | Integra LifeSciences Corporation | 7 |
| 2023-07-17 | WL | Warning Letter | TEI Biosciences, Inc. | — |
| 2023-05-17 | OAI | Official action indicated | TEI Biosciences, Inc. | 7 |
| 2023-03-24 | NAI | No action indicated | Integra Neurosciences | 0 |
| 2021-11-12 | VAI | Voluntary action indicated | TEI Biosciences, Inc. | 6 |
| 2021-07-15 | VAI | Voluntary action indicated | Surgical Innovation Associates Inc | 0 |
| 2019-08-23 | VAI | Voluntary action indicated | Integra Neurosciences | 5 |
| 2019-08-23 | NAI | No action indicated | Integra LifeSciences Corp. (NeuroSciences) | 0 |
| 2019-05-16 | NAI | No action indicated | REBOUND THERAPEUTICS, CORPORATION | 0 |
| 2019-03-06 | WL | Warning Letter | TEI Biosciences, Inc. | — |
| 2018-11-02 | OAI | Official action indicated | TEI Biosciences, Inc. | 0 |
| 2018-07-02 | VAI | Voluntary action indicated | Integra LifeSciences Corporation | 4 |
| 2018-07-02 | VAI | Voluntary action indicated | Integra LifeSciences Corporation | 4 |
| 2015-05-29 | WL | Warning Letter | TEI Biosciences, Inc. | — |
| 2013-04-26 | WL | Warning Letter | ACell, Inc | — |
| 2013-02-13 | WL | Warning Letter | Integra Neurosciences | — |
| 2011-12-21 | WL | Warning Letter | Integra LifeSciences Corporation | — |
| 2011-12-21 | WL | Warning Letter | Integra LifeSciences Corporation | — |
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