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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.

3 linked reportsMalfunction 3
25792019-01: 0 reports for this device; peer average 2.39/device2019-02: 0 reports for this device; peer average 2.93/device2019-03: 0 reports for this device; peer average 2.73/device2019-04: 0 reports for this device; peer average 2.39/device2019-05: 0 reports for this device; peer average 2.7/device2019-06: 0 reports for this device; peer average 2.44/device2019-07: 0 reports for this device; peer average 2.61/device2019-08: 0 reports for this device; peer average 2.51/device2019-09: 0 reports for this device; peer average 2.49/device2019-10: 0 reports for this device; peer average 3.33/device2019-11: 0 reports for this device; peer average 4.32/device2019-12: 0 reports for this device; peer average 2.92/device2020-01: 0 reports for this device; peer average 2.96/device2020-02: 0 reports for this device; peer average 3.99/device2020-03: 0 reports for this device; peer average 3.58/device2020-04: 0 reports for this device; peer average 6.2/device2020-05: 0 reports for this device; peer average 2.04/device2020-06: 0 reports for this device; peer average 2.89/device2020-07: 0 reports for this device; peer average 3.24/device2020-08: 0 reports for this device; peer average 2.31/device2020-09: 0 reports for this device; peer average 3.44/device2020-10: 0 reports for this device; peer average 4.41/device2020-11: 0 reports for this device; peer average 4.59/device2020-12: 0 reports for this device; peer average 3.72/device2021-01: 0 reports for this device; peer average 3.93/device2021-02: 0 reports for this device; peer average 3.43/device2021-03: 0 reports for this device; peer average 3.22/device2021-04: 0 reports for this device; peer average 3.18/device2021-05: 0 reports for this device; peer average 3.53/device2021-06: 0 reports for this device; peer average 3.32/device2021-07: 0 reports for this device; peer average 2.88/device2021-08: 0 reports for this device; peer average 2.72/device2021-09: 0 reports for this device; peer average 2.43/device2021-10: 0 reports for this device; peer average 2.23/device2021-11: 0 reports for this device; peer average 3.2/device2021-12: 0 reports for this device; peer average 2.66/device2022-01: 0 reports for this device; peer average 2.75/device2022-02: 0 reports for this device; peer average 2.99/device2022-03: 0 reports for this device; peer average 2.63/device2022-04: 0 reports for this device; peer average 2.28/device2022-05: 0 reports for this device; peer average 3.33/device2022-06: 0 reports for this device; peer average 3.42/device2022-07: 0 reports for this device; peer average 2.89/device2022-08: 0 reports for this device; peer average 2.53/device2022-09: 0 reports for this device; peer average 2.14/device2022-10: 0 reports for this device; peer average 3.18/device2022-11: 0 reports for this device; peer average 2.9/device2022-12: 0 reports for this device; peer average 3.31/device2023-01: 0 reports for this device; peer average 2.91/device2023-02: 0 reports for this device; peer average 2.84/device2023-03: 0 reports for this device; peer average 3.1/device2023-04: 0 reports for this device; peer average 2.59/device2023-05: 0 reports for this device; peer average 2.71/device2023-06: 0 reports for this device; peer average 2.37/device2023-07: 0 reports for this device; peer average 2.49/device2023-08: 0 reports for this device; peer average 2.19/device2023-09: 0 reports for this device; peer average 3.31/device2023-10: 0 reports for this device; peer average 2.85/device2023-11: 0 reports for this device; peer average 9.48/device2023-12: 0 reports for this device; peer average 3.98/device2024-01: 0 reports for this device; peer average 2.83/device2024-02: 0 reports for this device; peer average 3.54/device2024-03: 0 reports for this device; peer average 3.25/device2024-04: 0 reports for this device; peer average 3.17/device2024-05: 0 reports for this device; peer average 4.01/device2024-06: 0 reports for this device; peer average 3.67/device2024-07: 0 reports for this device; peer average 3.3/device2024-08: 0 reports for this device; peer average 3.92/device2024-09: 0 reports for this device; peer average 3.64/device2024-10: 0 reports for this device; peer average 4.74/device2024-11: 0 reports for this device; peer average 3.83/device2024-12: 0 reports for this device; peer average 3.3/device2025-01: 0 reports for this device; peer average 6.22/device2025-02: 0 reports for this device; peer average 3.54/device2025-03: 0 reports for this device; peer average 2.87/device2025-04: 1 reports for this device; peer average 3.25/device2025-05: 0 reports for this device; peer average 3.7/device2025-06: 0 reports for this device; peer average 3.51/device2025-07: 0 reports for this device; peer average 3.57/device2025-08: 0 reports for this device; peer average 4.15/device2025-09: 0 reports for this device; peer average 3.08/device2025-10: 0 reports for this device; peer average 3.38/device2025-11: 0 reports for this device; peer average 3.63/device2025-12: 0 reports for this device; peer average 3.85/device2026-01: 0 reports for this device; peer average 3.73/device2026-02: 0 reports for this device; peer average 3.3/device2026-03: 2 reports for this device; peer average 3.6/device2026-04: 0 reports for this device; peer average 3.13/device2026-05: 0 reports for this device; peer average 3.86/device2026-06: 0 reports for this device; peer average 3.28/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.39
2019-0202.93
2019-0302.73
2019-0402.39
2019-0502.7
2019-0602.44
2019-0702.61
2019-0802.51
2019-0902.49
2019-1003.33
2019-1104.32
2019-1202.92
2020-0102.96
2020-0203.99
2020-0303.58
2020-0406.2
2020-0502.04
2020-0602.89
2020-0703.24
2020-0802.31
2020-0903.44
2020-1004.41
2020-1104.59
2020-1203.72
2021-0103.93
2021-0203.43
2021-0303.22
2021-0403.18
2021-0503.53
2021-0603.32
2021-0702.88
2021-0802.72
2021-0902.43
2021-1002.23
2021-1103.2
2021-1202.66
2022-0102.75
2022-0202.99
2022-0302.63
2022-0402.28
2022-0503.33
2022-0603.42
2022-0702.89
2022-0802.53
2022-0902.14
2022-1003.18
2022-1102.9
2022-1203.31
2023-0102.91
2023-0202.84
2023-0303.1
2023-0402.59
2023-0502.71
2023-0602.37
2023-0702.49
2023-0802.19
2023-0903.31
2023-1002.85
2023-1109.48
2023-1203.98
2024-0102.83
2024-0203.54
2024-0303.25
2024-0403.17
2024-0504.01
2024-0603.67
2024-0703.3
2024-0803.92
2024-0903.64
2024-1004.74
2024-1103.83
2024-1203.3
2025-0106.22
2025-0203.54
2025-0302.87
2025-0413.25
2025-0503.7
2025-0603.51
2025-0703.57
2025-0804.15
2025-0903.08
2025-1003.38
2025-1103.63
2025-1203.85
2026-0103.73
2026-0203.3
2026-0323.6
2026-0403.13
2026-0503.86
2026-0603.28
This device (reports/month)Average device in MAX, OLO (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2026-03-123003120897-2026-00443MalfunctionAvailableexact di
2025-04-051030489-2025-01628MalfunctionAvailablemodel number

Showing the most recent 2 of 3 linked reports.

Regulatory clearances

    Predicate lineage

    Cited as predicate by: K212524, K214011

    Cited as predicate by: K222383, K230064, K251316

    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
    2026-02-06NAINo action indicatedMedtronic Sofamor Danek USA Inc0
    2017-10-26NAINo action indicatedMedtronic Sofamor Danek USA, Inc0
    2015-11-03VAIVoluntary action indicatedMedtronic Sofamor Danek USA Inc0
    2015-10-23VAIVoluntary action indicatedMedtronic Sofamor Danek USA Inc1
    2014-03-11VAIVoluntary action indicatedMedtronic Sofamor Danek USA Inc0
    2013-07-15NAINo action indicatedMedtronic Sofamor Danek USA, Inc0
    2013-07-15NAINo action indicatedMedtronic Sofamor Danek USA Inc0
    2012-06-06VAIVoluntary action indicatedMedtronic Sofamor Danek USA Inc0
    2011-02-23NAINo action indicatedMedtronic Sofamor Danek Usa Inc0
    2010-08-06VAIVoluntary action indicatedMedtronic Sofamor Danek USA Inc0
    2010-03-04VAIVoluntary action indicatedMedtronic Sofamor Danek USA Inc0
    2010-02-25NAINo action indicatedMedtronic Sofamor Danek USA Inc0
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