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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.

29 linked reportsMalfunction 15Injury 14
13462019-01: 1 reports for this device; peer average 2.23/device2019-02: 0 reports for this device; peer average 2.95/device2019-03: 1 reports for this device; peer average 1.95/device2019-04: 0 reports for this device; peer average 2.54/device2019-05: 0 reports for this device; peer average 2.58/device2019-06: 0 reports for this device; peer average 2.13/device2019-07: 0 reports for this device; peer average 2.88/device2019-08: 0 reports for this device; peer average 2.31/device2019-09: 0 reports for this device; peer average 2.59/device2019-10: 4 reports for this device; peer average 3.55/device2019-11: 0 reports for this device; peer average 2.61/device2019-12: 0 reports for this device; peer average 3.08/device2020-01: 0 reports for this device; peer average 2.65/device2020-02: 0 reports for this device; peer average 2.14/device2020-03: 3 reports for this device; peer average 2.57/device2020-04: 0 reports for this device; peer average 2.06/device2020-05: 0 reports for this device; peer average 2.2/device2020-06: 0 reports for this device; peer average 2.79/device2020-07: 0 reports for this device; peer average 3.4/device2020-08: 0 reports for this device; peer average 3.22/device2020-09: 5 reports for this device; peer average 3.04/device2020-10: 3 reports for this device; peer average 3.82/device2020-11: 0 reports for this device; peer average 4.24/device2020-12: 0 reports for this device; peer average 3.5/device2021-01: 0 reports for this device; peer average 4.53/device2021-02: 0 reports for this device; peer average 3.6/device2021-03: 0 reports for this device; peer average 3.73/device2021-04: 0 reports for this device; peer average 3.42/device2021-05: 0 reports for this device; peer average 3.39/device2021-06: 0 reports for this device; peer average 3.09/device2021-07: 0 reports for this device; peer average 3.34/device2021-08: 0 reports for this device; peer average 2.55/device2021-09: 0 reports for this device; peer average 3.23/device2021-10: 0 reports for this device; peer average 2.68/device2021-11: 0 reports for this device; peer average 3.38/device2021-12: 0 reports for this device; peer average 3.64/device2022-01: 0 reports for this device; peer average 3.69/device2022-02: 0 reports for this device; peer average 3.36/device2022-03: 3 reports for this device; peer average 3.02/device2022-04: 0 reports for this device; peer average 3.35/device2022-05: 0 reports for this device; peer average 2.79/device2022-06: 0 reports for this device; peer average 2.88/device2022-07: 0 reports for this device; peer average 3.37/device2022-08: 0 reports for this device; peer average 3.33/device2022-09: 0 reports for this device; peer average 4.38/device2022-10: 0 reports for this device; peer average 2.97/device2022-11: 3 reports for this device; peer average 3.63/device2022-12: 0 reports for this device; peer average 3.15/device2023-01: 0 reports for this device; peer average 3.5/device2023-02: 0 reports for this device; peer average 3.32/device2023-03: 0 reports for this device; peer average 3.94/device2023-04: 0 reports for this device; peer average 3.01/device2023-05: 0 reports for this device; peer average 4.21/device2023-06: 0 reports for this device; peer average 3.57/device2023-07: 0 reports for this device; peer average 3.65/device2023-08: 0 reports for this device; peer average 2.96/device2023-09: 0 reports for this device; peer average 2.53/device2023-10: 2 reports for this device; peer average 2.7/device2023-11: 0 reports for this device; peer average 2.46/device2023-12: 0 reports for this device; peer average 2.32/device2024-01: 0 reports for this device; peer average 2.51/device2024-02: 0 reports for this device; peer average 2.89/device2024-03: 2 reports for this device; peer average 2.61/device2024-04: 0 reports for this device; peer average 2.38/device2024-05: 0 reports for this device; peer average 3.31/device2024-06: 0 reports for this device; peer average 3/device2024-07: 0 reports for this device; peer average 3.19/device2024-08: 0 reports for this device; peer average 2.25/device2024-09: 0 reports for this device; peer average 3.85/device2024-10: 0 reports for this device; peer average 2.67/device2024-11: 0 reports for this device; peer average 2.56/device2024-12: 2 reports for this device; peer average 1.94/device2025-01: 0 reports for this device; peer average 5.71/device2025-02: 0 reports for this device; peer average 4.27/device2025-03: 0 reports for this device; peer average 2.71/device2025-04: 0 reports for this device; peer average 2.89/device2025-05: 0 reports for this device; peer average 3.18/device2025-06: 0 reports for this device; peer average 2.74/device2025-07: 0 reports for this device; peer average 2.97/device2025-08: 0 reports for this device; peer average 3.06/device2025-09: 0 reports for this device; peer average 2.47/device2025-10: 0 reports for this device; peer average 2.19/device2025-11: 0 reports for this device; peer average 2.86/device2025-12: 0 reports for this device; peer average 3.46/device2026-01: 0 reports for this device; peer average 3.06/device2026-02: 0 reports for this device; peer average 2.46/device2026-03: 0 reports for this device; peer average 2.72/device2026-04: 0 reports for this device; peer average 2.96/device2026-05: 0 reports for this device; peer average 2.98/device2026-06: 0 reports for this device; peer average 3.27/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0112.23
2019-0202.95
2019-0311.95
2019-0402.54
2019-0502.58
2019-0602.13
2019-0702.88
2019-0802.31
2019-0902.59
2019-1043.55
2019-1102.61
2019-1203.08
2020-0102.65
2020-0202.14
2020-0332.57
2020-0402.06
2020-0502.2
2020-0602.79
2020-0703.4
2020-0803.22
2020-0953.04
2020-1033.82
2020-1104.24
2020-1203.5
2021-0104.53
2021-0203.6
2021-0303.73
2021-0403.42
2021-0503.39
2021-0603.09
2021-0703.34
2021-0802.55
2021-0903.23
2021-1002.68
2021-1103.38
2021-1203.64
2022-0103.69
2022-0203.36
2022-0333.02
2022-0403.35
2022-0502.79
2022-0602.88
2022-0703.37
2022-0803.33
2022-0904.38
2022-1002.97
2022-1133.63
2022-1203.15
2023-0103.5
2023-0203.32
2023-0303.94
2023-0403.01
2023-0504.21
2023-0603.57
2023-0703.65
2023-0802.96
2023-0902.53
2023-1022.7
2023-1102.46
2023-1202.32
2024-0102.51
2024-0202.89
2024-0322.61
2024-0402.38
2024-0503.31
2024-0603
2024-0703.19
2024-0802.25
2024-0903.85
2024-1002.67
2024-1102.56
2024-1221.94
2025-0105.71
2025-0204.27
2025-0302.71
2025-0402.89
2025-0503.18
2025-0602.74
2025-0702.97
2025-0803.06
2025-0902.47
2025-1002.19
2025-1102.86
2025-1203.46
2026-0103.06
2026-0202.46
2026-0302.72
2026-0402.96
2026-0502.98
2026-0603.27
This device (reports/month)Average device in HXX (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2024-12-183005739886-2024-00071InjuryAvailablecatalog number
2024-03-283005739886-2024-00020MalfunctionAvailablecatalog number
2023-10-303005739886-2023-00059InjuryAvailablecatalog number
2022-11-143005739886-2022-00035InjuryAvailablecatalog number
2022-03-103005739886-2022-00007MalfunctionAvailablecatalog number
2020-10-063005739886-2020-00027InjuryAvailablecatalog number
2020-09-033005739886-2020-00022MalfunctionAvailablecatalog number
2020-09-033005739886-2020-00023MalfunctionAvailableexact di
2020-03-103005739886-2020-00010InjuryAvailablecatalog number
2019-10-243005739886-2019-00046MalfunctionAvailablecatalog number
2019-10-173005739886-2019-00044MalfunctionAvailablecatalog number
2019-03-283005739886-2019-00009InjuryAvailablecatalog number
2019-01-143005739886-2019-00001MalfunctionAvailablecatalog number

Showing the most recent 13 of 29 linked reports.

Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2017-08-11NAINo action indicatedPrecision Spine Inc0
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