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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.

790 linked reportsInjury 790
2551761022019-01: 0 reports for this device; peer average 4.02/device2019-02: 0 reports for this device; peer average 5.49/device2019-03: 0 reports for this device; peer average 4.31/device2019-04: 0 reports for this device; peer average 4.35/device2019-05: 0 reports for this device; peer average 4.17/device2019-06: 0 reports for this device; peer average 7.53/device2019-07: 0 reports for this device; peer average 6.39/device2019-08: 0 reports for this device; peer average 5.67/device2019-09: 75 reports for this device; peer average 101.74/device2019-10: 10 reports for this device; peer average 19.81/device2019-11: 10 reports for this device; peer average 16.08/device2019-12: 19 reports for this device; peer average 30.69/device2020-01: 14 reports for this device; peer average 21.27/device2020-02: 8 reports for this device; peer average 20.62/device2020-03: 14 reports for this device; peer average 27.38/device2020-04: 3 reports for this device; peer average 11.97/device2020-05: 10 reports for this device; peer average 16.48/device2020-06: 16 reports for this device; peer average 19.79/device2020-07: 8 reports for this device; peer average 20.77/device2020-08: 0 reports for this device; peer average 21.31/device2020-09: 4 reports for this device; peer average 21.29/device2020-10: 3 reports for this device; peer average 24.87/device2020-11: 12 reports for this device; peer average 25.78/device2020-12: 8 reports for this device; peer average 23.76/device2021-01: 5 reports for this device; peer average 25.39/device2021-02: 8 reports for this device; peer average 23.01/device2021-03: 12 reports for this device; peer average 26.58/device2021-04: 2 reports for this device; peer average 27.25/device2021-05: 5 reports for this device; peer average 26.71/device2021-06: 3 reports for this device; peer average 25.72/device2021-07: 2 reports for this device; peer average 26.62/device2021-08: 8 reports for this device; peer average 25.87/device2021-09: 15 reports for this device; peer average 26.57/device2021-10: 0 reports for this device; peer average 13.4/device2021-11: 12 reports for this device; peer average 37.66/device2021-12: 4 reports for this device; peer average 40.89/device2022-01: 26 reports for this device; peer average 37.75/device2022-02: 16 reports for this device; peer average 34.42/device2022-03: 2 reports for this device; peer average 36.79/device2022-04: 6 reports for this device; peer average 35.22/device2022-05: 26 reports for this device; peer average 37.22/device2022-06: 6 reports for this device; peer average 36.79/device2022-07: 16 reports for this device; peer average 35.39/device2022-08: 4 reports for this device; peer average 37.6/device2022-09: 4 reports for this device; peer average 36.7/device2022-10: 8 reports for this device; peer average 42.21/device2022-11: 12 reports for this device; peer average 39.36/device2022-12: 8 reports for this device; peer average 41.85/device2023-01: 8 reports for this device; peer average 34.77/device2023-02: 0 reports for this device; peer average 35.66/device2023-03: 12 reports for this device; peer average 41.37/device2023-04: 10 reports for this device; peer average 38.17/device2023-05: 6 reports for this device; peer average 41.87/device2023-06: 12 reports for this device; peer average 45.96/device2023-07: 3 reports for this device; peer average 39.31/device2023-08: 18 reports for this device; peer average 33.01/device2023-09: 17 reports for this device; peer average 31.49/device2023-10: 22 reports for this device; peer average 33.43/device2023-11: 4 reports for this device; peer average 36.94/device2023-12: 8 reports for this device; peer average 34.53/device2024-01: 14 reports for this device; peer average 34.21/device2024-02: 18 reports for this device; peer average 34.57/device2024-03: 4 reports for this device; peer average 34.07/device2024-04: 14 reports for this device; peer average 37.37/device2024-05: 5 reports for this device; peer average 34.78/device2024-06: 8 reports for this device; peer average 33.12/device2024-07: 14 reports for this device; peer average 32.62/device2024-08: 8 reports for this device; peer average 31.39/device2024-09: 2 reports for this device; peer average 36.84/device2024-10: 10 reports for this device; peer average 36.67/device2024-11: 2 reports for this device; peer average 30.96/device2024-12: 3 reports for this device; peer average 26.15/device2025-01: 8 reports for this device; peer average 24.35/device2025-02: 13 reports for this device; peer average 23.19/device2025-03: 3 reports for this device; peer average 25.54/device2025-04: 0 reports for this device; peer average 14.63/device2025-05: 0 reports for this device; peer average 10.86/device2025-06: 16 reports for this device; peer average 51.12/device2025-07: 4 reports for this device; peer average 38.65/device2025-08: 6 reports for this device; peer average 31.25/device2025-09: 12 reports for this device; peer average 24.9/device2025-10: 3 reports for this device; peer average 23.31/device2025-11: 7 reports for this device; peer average 25.93/device2025-12: 18 reports for this device; peer average 29.86/device2026-01: 14 reports for this device; peer average 27.04/device2026-02: 8 reports for this device; peer average 27.07/device2026-03: 6 reports for this device; peer average 26.64/device2026-04: 16 reports for this device; peer average 25.99/device2026-05: 8 reports for this device; peer average 26.41/device2026-06: 2 reports for this device; peer average 27.45/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0104.02
2019-0205.49
2019-0304.31
2019-0404.35
2019-0504.17
2019-0607.53
2019-0706.39
2019-0805.67
2019-0975101.74
2019-101019.81
2019-111016.08
2019-121930.69
2020-011421.27
2020-02820.62
2020-031427.38
2020-04311.97
2020-051016.48
2020-061619.79
2020-07820.77
2020-08021.31
2020-09421.29
2020-10324.87
2020-111225.78
2020-12823.76
2021-01525.39
2021-02823.01
2021-031226.58
2021-04227.25
2021-05526.71
2021-06325.72
2021-07226.62
2021-08825.87
2021-091526.57
2021-10013.4
2021-111237.66
2021-12440.89
2022-012637.75
2022-021634.42
2022-03236.79
2022-04635.22
2022-052637.22
2022-06636.79
2022-071635.39
2022-08437.6
2022-09436.7
2022-10842.21
2022-111239.36
2022-12841.85
2023-01834.77
2023-02035.66
2023-031241.37
2023-041038.17
2023-05641.87
2023-061245.96
2023-07339.31
2023-081833.01
2023-091731.49
2023-102233.43
2023-11436.94
2023-12834.53
2024-011434.21
2024-021834.57
2024-03434.07
2024-041437.37
2024-05534.78
2024-06833.12
2024-071432.62
2024-08831.39
2024-09236.84
2024-101036.67
2024-11230.96
2024-12326.15
2025-01824.35
2025-021323.19
2025-03325.54
2025-04014.63
2025-05010.86
2025-061651.12
2025-07438.65
2025-08631.25
2025-091224.9
2025-10323.31
2025-11725.93
2025-121829.86
2026-011427.04
2026-02827.07
2026-03626.64
2026-041625.99
2026-05826.41
2026-06227.45
This device (reports/month)Average device in DZE (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
2026-06-290009613348-2026-009985InjuryAvailablecatalog number
2026-05-290009613348-2026-008158InjuryAvailablecatalog number
2026-05-110009613348-2026-007187InjuryAvailablecatalog number
2026-05-060009613348-2026-006744InjuryAvailablecatalog number
2026-05-060009613348-2026-006744InjuryAvailablecatalog number
2026-04-170009613348-2026-005784InjuryAvailablecatalog number
2026-04-070009613348-2026-005164InjuryAvailablecatalog number
2026-04-070009613348-2026-004946InjuryAvailablecatalog number
2026-04-070009613348-2026-004939InjuryAvailablecatalog number
2026-04-070009613348-2026-004938InjuryAvailablecatalog number
2026-04-070009613348-2026-004939InjuryAvailablecatalog number
2026-04-070009613348-2026-004938InjuryAvailablecatalog number
2026-04-070009613348-2026-004946InjuryAvailablecatalog number
2026-03-230009613348-2026-004156InjuryAvailablecatalog number
2026-03-230009613348-2026-004172InjuryAvailablecatalog number

Showing the most recent 200 of 790 linked reports.

Showing 1–15 of 200
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
    2018-08-30VAIVoluntary action indicatedStraumann Manufacturing, Inc2
    2017-12-07VAIVoluntary action indicatedJjgc Industria E Comercio De Materials Dentarios Sa4
    2017-07-21VAIVoluntary action indicatedStraumann USA LLC6
    2016-06-02OAIOfficial action indicatedANTHOGYR SAS5
    2014-11-13NAINo action indicatedStraumann USA LLC0
    2014-11-13NAINo action indicatedStraumann USA LLC0
    2014-09-03NAINo action indicatedBiora AB0
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