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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.

131 linked reportsInjury 67Malfunction 64
51015202019-01: 0 reports for this device; peer average 2.14/device2019-02: 0 reports for this device; peer average 2.01/device2019-03: 0 reports for this device; peer average 1.92/device2019-04: 2 reports for this device; peer average 2.04/device2019-05: 0 reports for this device; peer average 2.24/device2019-06: 0 reports for this device; peer average 2.38/device2019-07: 0 reports for this device; peer average 1.65/device2019-08: 0 reports for this device; peer average 2.74/device2019-09: 2 reports for this device; peer average 1.77/device2019-10: 2 reports for this device; peer average 1.88/device2019-11: 0 reports for this device; peer average 2.28/device2019-12: 0 reports for this device; peer average 1.57/device2020-01: 4 reports for this device; peer average 2.39/device2020-02: 8 reports for this device; peer average 2.28/device2020-03: 0 reports for this device; peer average 2.35/device2020-04: 0 reports for this device; peer average 1.52/device2020-05: 0 reports for this device; peer average 2.43/device2020-06: 2 reports for this device; peer average 1.84/device2020-07: 0 reports for this device; peer average 1.88/device2020-08: 0 reports for this device; peer average 1.96/device2020-09: 0 reports for this device; peer average 2.3/device2020-10: 0 reports for this device; peer average 2.58/device2020-11: 0 reports for this device; peer average 2.3/device2020-12: 0 reports for this device; peer average 2.02/device2021-01: 0 reports for this device; peer average 2.24/device2021-02: 0 reports for this device; peer average 1.86/device2021-03: 0 reports for this device; peer average 2.4/device2021-04: 0 reports for this device; peer average 2.23/device2021-05: 1 reports for this device; peer average 1.98/device2021-06: 8 reports for this device; peer average 2.12/device2021-07: 2 reports for this device; peer average 5.33/device2021-08: 0 reports for this device; peer average 1.95/device2021-09: 0 reports for this device; peer average 1.83/device2021-10: 0 reports for this device; peer average 2.42/device2021-11: 0 reports for this device; peer average 2.14/device2021-12: 0 reports for this device; peer average 2.24/device2022-01: 2 reports for this device; peer average 2.12/device2022-02: 0 reports for this device; peer average 2.02/device2022-03: 0 reports for this device; peer average 1.79/device2022-04: 3 reports for this device; peer average 1.91/device2022-05: 2 reports for this device; peer average 1.79/device2022-06: 3 reports for this device; peer average 2.01/device2022-07: 0 reports for this device; peer average 4.01/device2022-08: 0 reports for this device; peer average 1.84/device2022-09: 0 reports for this device; peer average 2.69/device2022-10: 0 reports for this device; peer average 1.5/device2022-11: 0 reports for this device; peer average 1.69/device2022-12: 11 reports for this device; peer average 2.11/device2023-01: 4 reports for this device; peer average 1.78/device2023-02: 2 reports for this device; peer average 1.81/device2023-03: 0 reports for this device; peer average 1.71/device2023-04: 2 reports for this device; peer average 1.96/device2023-05: 2 reports for this device; peer average 1.57/device2023-06: 0 reports for this device; peer average 1.7/device2023-07: 1 reports for this device; peer average 1.89/device2023-08: 0 reports for this device; peer average 1.75/device2023-09: 0 reports for this device; peer average 2.59/device2023-10: 0 reports for this device; peer average 2.57/device2023-11: 0 reports for this device; peer average 2.32/device2023-12: 0 reports for this device; peer average 1.68/device2024-01: 0 reports for this device; peer average 2.42/device2024-02: 8 reports for this device; peer average 2.22/device2024-03: 2 reports for this device; peer average 3.62/device2024-04: 0 reports for this device; peer average 1.71/device2024-05: 0 reports for this device; peer average 3.53/device2024-06: 0 reports for this device; peer average 2.64/device2024-07: 0 reports for this device; peer average 1.86/device2024-08: 0 reports for this device; peer average 1.9/device2024-09: 3 reports for this device; peer average 3.11/device2024-10: 0 reports for this device; peer average 2.27/device2024-11: 4 reports for this device; peer average 2.04/device2024-12: 2 reports for this device; peer average 1.93/device2025-01: 0 reports for this device; peer average 2.32/device2025-02: 4 reports for this device; peer average 2.55/device2025-03: 2 reports for this device; peer average 2.28/device2025-04: 0 reports for this device; peer average 2.32/device2025-05: 2 reports for this device; peer average 2.57/device2025-06: 20 reports for this device; peer average 2.27/device2025-07: 8 reports for this device; peer average 1.81/device2025-08: 0 reports for this device; peer average 1.99/device2025-09: 1 reports for this device; peer average 1.84/device2025-10: 0 reports for this device; peer average 1.87/device2025-11: 0 reports for this device; peer average 2/device2025-12: 2 reports for this device; peer average 2.47/device2026-01: 0 reports for this device; peer average 2.33/device2026-02: 4 reports for this device; peer average 2.41/device2026-03: 0 reports for this device; peer average 2.36/device2026-04: 6 reports for this device; peer average 1.88/device2026-05: 0 reports for this device; peer average 2.23/device2026-06: 0 reports for this device; peer average 4.04/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.14
2019-0202.01
2019-0301.92
2019-0422.04
2019-0502.24
2019-0602.38
2019-0701.65
2019-0802.74
2019-0921.77
2019-1021.88
2019-1102.28
2019-1201.57
2020-0142.39
2020-0282.28
2020-0302.35
2020-0401.52
2020-0502.43
2020-0621.84
2020-0701.88
2020-0801.96
2020-0902.3
2020-1002.58
2020-1102.3
2020-1202.02
2021-0102.24
2021-0201.86
2021-0302.4
2021-0402.23
2021-0511.98
2021-0682.12
2021-0725.33
2021-0801.95
2021-0901.83
2021-1002.42
2021-1102.14
2021-1202.24
2022-0122.12
2022-0202.02
2022-0301.79
2022-0431.91
2022-0521.79
2022-0632.01
2022-0704.01
2022-0801.84
2022-0902.69
2022-1001.5
2022-1101.69
2022-12112.11
2023-0141.78
2023-0221.81
2023-0301.71
2023-0421.96
2023-0521.57
2023-0601.7
2023-0711.89
2023-0801.75
2023-0902.59
2023-1002.57
2023-1102.32
2023-1201.68
2024-0102.42
2024-0282.22
2024-0323.62
2024-0401.71
2024-0503.53
2024-0602.64
2024-0701.86
2024-0801.9
2024-0933.11
2024-1002.27
2024-1142.04
2024-1221.93
2025-0102.32
2025-0242.55
2025-0322.28
2025-0402.32
2025-0522.57
2025-06202.27
2025-0781.81
2025-0801.99
2025-0911.84
2025-1001.87
2025-1102
2025-1222.47
2026-0102.33
2026-0242.41
2026-0302.36
2026-0461.88
2026-0502.23
2026-0604.04
This device (reports/month)Average device in KWP, NKB (reports/device/month)
Failure-mode summaryAI-generated

40 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2026-04-022027467-2026-00058InjuryAvailableexact di
2026-04-022027467-2026-00057MalfunctionAvailableexact di
2026-04-022027467-2026-00059InjuryAvailableexact di
2026-02-242027467-2026-00031MalfunctionAvailableexact di
2026-02-182027467-2026-00022InjuryAvailableexact di
2025-12-312027467-2025-00281InjuryAvailableexact di
2025-09-242027467-2025-00221MalfunctionAvailablemodel number
2025-07-222027467-2025-00178MalfunctionAvailableexact di
2025-07-222027467-2025-00179MalfunctionAvailableexact di
2025-07-162027467-2025-00173MalfunctionAvailableexact di
2025-07-162027467-2025-00172MalfunctionAvailableexact di
2025-06-232027467-2025-00148InjuryAvailableexact di
2025-06-232027467-2025-00147MalfunctionAvailableexact di
2025-06-232027467-2025-00146InjuryAvailableexact di
2025-06-232027467-2025-00149InjuryAvailableexact di

Showing the most recent 69 of 131 linked reports.

Showing 1–15 of 69
Regulatory clearances

    Predicate lineage

    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
    DateTypeOutcomeFacilityCitations
    2017-04-19VAIVoluntary action indicatedAlphatec Spine, Inc.1
    2016-03-16VAIVoluntary action indicatedAlphatec Spine, Inc.1
    2015-07-16WLWarning LetterAlphatec Spine, Inc.—
    2015-03-13OAIOfficial action indicatedAlphatec Spine, Inc.0
    2013-06-14NAINo action indicatedAlphatec Spine, Inc.0
    2012-04-27VAIVoluntary action indicatedAlphatec Spine, Inc.0
    2011-01-11WLWarning LetterAlphatec Spine, Inc.—
    2010-12-13VAIVoluntary action indicatedAlphatec Spine, Inc.7
    2010-06-21WLWarning LetterAlphatec Spine, Inc.—
    2010-02-11OAIOfficial action indicatedAlphatec Spine, Inc.11
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