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.
41 linked reportsInjury 22Malfunction 19
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.81 |
| 2019-02 | 0 | 1.74 |
| 2019-03 | 0 | 1.72 |
| 2019-04 | 0 | 1.79 |
| 2019-05 | 0 | 2.02 |
| 2019-06 | 0 | 1.86 |
| 2019-07 | 0 | 1.58 |
| 2019-08 | 0 | 2.14 |
| 2019-09 | 1 | 1.65 |
| 2019-10 | 4 | 1.82 |
| 2019-11 | 0 | 1.7 |
| 2019-12 | 1 | 1.74 |
| 2020-01 | 0 | 1.98 |
| 2020-02 | 0 | 2.11 |
| 2020-03 | 1 | 1.99 |
| 2020-04 | 0 | 1.77 |
| 2020-05 | 0 | 1.65 |
| 2020-06 | 0 | 1.92 |
| 2020-07 | 0 | 2.16 |
| 2020-08 | 0 | 1.79 |
| 2020-09 | 0 | 1.97 |
| 2020-10 | 1 | 2.11 |
| 2020-11 | 2 | 1.88 |
| 2020-12 | 0 | 1.84 |
| 2021-01 | 0 | 2.11 |
| 2021-02 | 0 | 2.02 |
| 2021-03 | 1 | 2.13 |
| 2021-04 | 0 | 2.02 |
| 2021-05 | 0 | 1.96 |
| 2021-06 | 0 | 1.8 |
| 2021-07 | 0 | 2.05 |
| 2021-08 | 0 | 2.2 |
| 2021-09 | 0 | 1.94 |
| 2021-10 | 0 | 2.13 |
| 2021-11 | 0 | 2.1 |
| 2021-12 | 0 | 2.39 |
| 2022-01 | 0 | 2.54 |
| 2022-02 | 0 | 2.33 |
| 2022-03 | 0 | 2.38 |
| 2022-04 | 3 | 2.39 |
| 2022-05 | 0 | 2.1 |
| 2022-06 | 3 | 2.2 |
| 2022-07 | 0 | 2.23 |
| 2022-08 | 0 | 2.2 |
| 2022-09 | 0 | 2.01 |
| 2022-10 | 0 | 2.06 |
| 2022-11 | 0 | 2.07 |
| 2022-12 | 0 | 2.01 |
| 2023-01 | 0 | 1.84 |
| 2023-02 | 0 | 1.96 |
| 2023-03 | 0 | 2.05 |
| 2023-04 | 2 | 2.17 |
| 2023-05 | 4 | 2.1 |
| 2023-06 | 6 | 2.27 |
| 2023-07 | 0 | 2.05 |
| 2023-08 | 0 | 1.7 |
| 2023-09 | 0 | 1.52 |
| 2023-10 | 1 | 1.62 |
| 2023-11 | 0 | 1.63 |
| 2023-12 | 0 | 1.43 |
| 2024-01 | 0 | 1.79 |
| 2024-02 | 1 | 1.78 |
| 2024-03 | 1 | 1.66 |
| 2024-04 | 0 | 1.83 |
| 2024-05 | 0 | 1.64 |
| 2024-06 | 1 | 1.88 |
| 2024-07 | 0 | 1.56 |
| 2024-08 | 1 | 1.71 |
| 2024-09 | 0 | 1.67 |
| 2024-10 | 0 | 1.69 |
| 2024-11 | 2 | 1.58 |
| 2024-12 | 0 | 1.6 |
| 2025-01 | 0 | 1.7 |
| 2025-02 | 0 | 1.6 |
| 2025-03 | 0 | 1.88 |
| 2025-04 | 0 | 1.68 |
| 2025-05 | 0 | 1.74 |
| 2025-06 | 1 | 1.87 |
| 2025-07 | 1 | 1.74 |
| 2025-08 | 0 | 1.58 |
| 2025-09 | 1 | 1.5 |
| 2025-10 | 2 | 1.63 |
| 2025-11 | 0 | 1.75 |
| 2025-12 | 0 | 2.15 |
| 2026-01 | 0 | 1.88 |
| 2026-02 | 0 | 1.83 |
| 2026-03 | 0 | 1.74 |
| 2026-04 | 0 | 1.72 |
| 2026-05 | 0 | 1.72 |
| 2026-06 | 0 | 1.77 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2023-06-12 | Z-2019-2023 | Class II | Open, Classified | A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Assembly Screw 0mm Short (ARS655118) & vice versa.Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, Netherlands, Spain, United Kingdom. | 55 units | code info di |
| 2023-06-12 | Z-2020-2023 | Class II | Open, Classified | A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Assembly Screw 0mm Short (ARS655118) & vice versa.Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Canada, Netherlands, Spain, United Kingdom. | 55 units | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-10-15 | 0001649390-2025-00712 | Injury | Available | catalog number |
| 2025-10-15 | 0001649390-2025-00715 | Injury | Available | catalog number |
| 2025-09-22 | 0001649390-2025-00671 | Injury | Available | catalog number |
| 2025-07-21 | 0001649390-2025-00530 | Injury | Available | catalog number |
| 2025-06-05 | 0001649390-2025-00382 | Injury | Available | catalog number |
| 2024-11-28 | 0001649390-2024-00679 | Injury | Available | catalog number |
| 2024-11-20 | 0001649390-2024-00667 | Injury | Available | catalog number |
| 2024-08-29 | 0001649390-2024-00417 | Injury | Available | catalog number |
| 2024-06-04 | 0001649390-2024-00249 | Injury | Available | catalog number |
| 2024-03-25 | 0001649390-2024-00134 | Injury | Available | catalog number |
| 2024-02-26 | 0001649390-2024-00062 | Injury | Available | catalog number |
| 2023-10-09 | 0001649390-2023-00248 | Injury | Available | catalog number |
| 2023-06-30 | 0001649390-2023-00158 | Malfunction | Available | catalog number |
| 2023-06-27 | 0001649390-2023-00148 | Malfunction | Available | catalog number |
| 2023-06-27 | 0001649390-2023-00147 | Malfunction | Available | catalog number |
Showing the most recent 37 of 41 linked reports.
Showing 1–15 of 37
Regulatory clearances
None linked.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2015-07-15 | NAI | No action indicated | Tornier, Inc | 0 |
| 2015-01-22 | NAI | No action indicated | Tornier Inc. | 0 |
| 2014-03-26 | NAI | No action indicated | Tornier, Inc | 0 |
| 2013-01-31 | VAI | Voluntary action indicated | Tornier, Inc | 4 |
| 2011-11-03 | NAI | No action indicated | Tornier, Inc | 0 |
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