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.
57 linked reportsMalfunction 53Injury 4
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.33 |
| 2019-02 | 0 | 2 |
| 2019-03 | 0 | 2 |
| 2019-04 | 0 | 1.14 |
| 2019-05 | 0 | 1.33 |
| 2019-06 | 0 | 1.86 |
| 2019-07 | 0 | 1.44 |
| 2019-08 | 0 | 1.25 |
| 2019-09 | 0 | 3 |
| 2019-10 | 0 | 4 |
| 2019-11 | 0 | 1.4 |
| 2019-12 | 0 | 1.83 |
| 2020-01 | 0 | 2 |
| 2020-02 | 0 | 2.4 |
| 2020-03 | 0 | 1.69 |
| 2020-04 | 0 | 1 |
| 2020-05 | 0 | 1.4 |
| 2020-06 | 0 | 4.5 |
| 2020-07 | 0 | 4.8 |
| 2020-08 | 0 | 1.33 |
| 2020-09 | 0 | 5 |
| 2020-10 | 0 | 2.63 |
| 2020-11 | 0 | 3.38 |
| 2020-12 | 0 | 1.29 |
| 2021-01 | 0 | 2.67 |
| 2021-02 | 0 | 2 |
| 2021-03 | 0 | 1.82 |
| 2021-04 | 0 | 2 |
| 2021-05 | 0 | 2.71 |
| 2021-06 | 0 | 2.78 |
| 2021-07 | 0 | 3 |
| 2021-08 | 0 | 2.86 |
| 2021-09 | 0 | 1.7 |
| 2021-10 | 0 | 2.71 |
| 2021-11 | 0 | 2.33 |
| 2021-12 | 0 | 3.13 |
| 2022-01 | 0 | 3.67 |
| 2022-02 | 0 | 3.71 |
| 2022-03 | 0 | 2 |
| 2022-04 | 0 | 1.75 |
| 2022-05 | 0 | 2.63 |
| 2022-06 | 0 | 1.56 |
| 2022-07 | 0 | 1.89 |
| 2022-08 | 0 | 3 |
| 2022-09 | 0 | 2.29 |
| 2022-10 | 0 | 1.75 |
| 2022-11 | 0 | 1.57 |
| 2022-12 | 0 | 1.62 |
| 2023-01 | 0 | 1.75 |
| 2023-02 | 0 | 1.5 |
| 2023-03 | 0 | 1.78 |
| 2023-04 | 0 | 2.11 |
| 2023-05 | 0 | 1.43 |
| 2023-06 | 0 | 1.33 |
| 2023-07 | 0 | 1.8 |
| 2023-08 | 0 | 1.62 |
| 2023-09 | 0 | 1.67 |
| 2023-10 | 2 | 1.29 |
| 2023-11 | 10 | 2.33 |
| 2023-12 | 2 | 1.33 |
| 2024-01 | 0 | 1.91 |
| 2024-02 | 0 | 1.83 |
| 2024-03 | 2 | 1.64 |
| 2024-04 | 4 | 2.33 |
| 2024-05 | 2 | 2.33 |
| 2024-06 | 2 | 1.86 |
| 2024-07 | 0 | 2.14 |
| 2024-08 | 4 | 1.83 |
| 2024-09 | 0 | 1.79 |
| 2024-10 | 4 | 1.86 |
| 2024-11 | 6 | 1.83 |
| 2024-12 | 2 | 2.57 |
| 2025-01 | 0 | 1.4 |
| 2025-02 | 3 | 1.5 |
| 2025-03 | 2 | 1.55 |
| 2025-04 | 2 | 1.57 |
| 2025-05 | 0 | 1.6 |
| 2025-06 | 2 | 1.67 |
| 2025-07 | 2 | 2.8 |
| 2025-08 | 0 | 1.57 |
| 2025-09 | 4 | 2.11 |
| 2025-10 | 0 | 1.75 |
| 2025-11 | 0 | 1 |
| 2025-12 | 0 | 1.73 |
| 2026-01 | 0 | 1 |
| 2026-02 | 0 | 1.36 |
| 2026-03 | 2 | 2.25 |
| 2026-04 | 0 | 1.7 |
| 2026-05 | 0 | 1.56 |
| 2026-06 | 0 | 1.73 |
Failure-mode summaryAI-generated
40 linked report narratives available — no AI summary generated yet.
Recall history
No recalls linked.
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2026-03-11 | 2027467-2026-00043 | Malfunction | Available | exact di |
| 2025-09-17 | 2027467-2025-00217 | Malfunction | Available | exact di |
| 2025-09-04 | 2027467-2025-00212 | Malfunction | Available | exact di |
| 2025-07-10 | 2027467-2025-00171 | Malfunction | Available | exact di |
| 2025-06-07 | 2027467-2025-00116 | Malfunction | Available | exact di |
| 2025-04-30 | 2027467-2025-00067 | Malfunction | Available | exact di |
| 2025-03-06 | 2027467-2025-00023 | Malfunction | Available | exact di |
| 2025-02-27 | 2027467-2025-00017 | Malfunction | Available | model number |
| 2025-02-26 | 2027467-2025-00020 | Malfunction | Available | exact di |
| 2024-12-06 | 2027467-2024-00161 | Malfunction | Available | exact di |
| 2024-11-15 | 2027467-2024-00147 | Injury | Available | exact di |
| 2024-11-01 | 2027467-2024-00134 | Malfunction | Available | exact di |
| 2024-11-01 | 2027467-2024-00135 | Malfunction | Available | exact di |
| 2024-10-21 | 2027467-2024-00119 | Malfunction | Available | exact di |
| 2024-10-17 | 2027467-2024-00126 | Malfunction | Available | exact di |
Showing the most recent 29 of 57 linked reports.
Showing 1–15 of 29
Regulatory clearances
Predicate lineage
- K203742
Cited as predicate by: K213935, K214006, K220782, K240951, K251575
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 |
|---|---|---|---|---|
| 2017-04-19 | VAI | Voluntary action indicated | Alphatec Spine, Inc. | 1 |
| 2016-03-16 | VAI | Voluntary action indicated | Alphatec Spine, Inc. | 1 |
| 2015-07-16 | WL | Warning Letter | Alphatec Spine, Inc. | — |
| 2015-03-13 | OAI | Official action indicated | Alphatec Spine, Inc. | 0 |
| 2013-06-14 | NAI | No action indicated | Alphatec Spine, Inc. | 0 |
| 2012-04-27 | VAI | Voluntary action indicated | Alphatec Spine, Inc. | 0 |
| 2011-01-11 | WL | Warning Letter | Alphatec Spine, Inc. | — |
| 2010-12-13 | VAI | Voluntary action indicated | Alphatec Spine, Inc. | 7 |
| 2010-06-21 | WL | Warning Letter | Alphatec Spine, Inc. | — |
| 2010-02-11 | OAI | Official action indicated | Alphatec Spine, Inc. | 11 |
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