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.
19 linked reportsMalfunction 14Injury 5
| 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 | 2 | 1.75 |
| 2022-05 | 0 | 2.63 |
| 2022-06 | 1 | 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 | 1 | 1.5 |
| 2023-03 | 0 | 1.78 |
| 2023-04 | 0 | 2.11 |
| 2023-05 | 0 | 1.43 |
| 2023-06 | 0 | 1.33 |
| 2023-07 | 2 | 1.8 |
| 2023-08 | 0 | 1.62 |
| 2023-09 | 2 | 1.67 |
| 2023-10 | 0 | 1.29 |
| 2023-11 | 0 | 2.33 |
| 2023-12 | 0 | 1.33 |
| 2024-01 | 0 | 1.91 |
| 2024-02 | 0 | 1.83 |
| 2024-03 | 0 | 1.64 |
| 2024-04 | 0 | 2.33 |
| 2024-05 | 0 | 2.33 |
| 2024-06 | 0 | 1.86 |
| 2024-07 | 0 | 2.14 |
| 2024-08 | 0 | 1.83 |
| 2024-09 | 0 | 1.79 |
| 2024-10 | 0 | 1.86 |
| 2024-11 | 0 | 1.83 |
| 2024-12 | 0 | 2.57 |
| 2025-01 | 0 | 1.4 |
| 2025-02 | 0 | 1.5 |
| 2025-03 | 4 | 1.55 |
| 2025-04 | 0 | 1.57 |
| 2025-05 | 0 | 1.6 |
| 2025-06 | 0 | 1.67 |
| 2025-07 | 6 | 2.8 |
| 2025-08 | 0 | 1.57 |
| 2025-09 | 1 | 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 | 0 | 2.25 |
| 2026-04 | 0 | 1.7 |
| 2026-05 | 0 | 1.56 |
| 2026-06 | 0 | 1.73 |
Failure-mode summaryAI-generated
19 linked report narratives available — no AI summary generated yet.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2024-01-26 | Z-1182-2024 | Class II | Open, Classified | Due to reports of intraoperative graft bolt implantation breakages.Distribution: Worldwide - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, IA, ID, IN, KS, KY, MD, MI, MN, MS, NC, NH, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, WA and WI. The country of New Zealand. | 12,777 devices | code info di |
Individual MAUDE reports
| Date | Report # | Type | Narrative | Link basis |
|---|---|---|---|---|
| 2025-09-25 | 2027467-2025-00223 | Malfunction | Available | model number |
| 2025-07-24 | 2027467-2025-00183 | Malfunction | Available | exact di |
| 2025-07-01 | 2027467-2025-00161 | Malfunction | Available | exact di |
| 2025-07-01 | 2027467-2025-00160 | Malfunction | Available | exact di |
| 2025-03-28 | 2027467-2025-00037 | Malfunction | Available | exact di |
| 2025-03-21 | 2027467-2025-00052 | Injury | Available | exact di |
| 2023-09-14 | 2027467-2023-00058 | Malfunction | Available | exact di |
| 2023-07-27 | 2027467-2023-00045 | Malfunction | Available | exact di |
| 2023-02-04 | 2027467-2023-00003 | Malfunction | Available | model number |
| 2022-06-22 | 2027467-2022-00042 | Injury | Available | model number |
| 2022-04-07 | 2027467-2022-00011 | Injury | Available | exact di |
Showing the most recent 11 of 19 linked reports.
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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