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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.

82 linked reportsMalfunction 67Injury 15
368112019-01: 0 reports for this device; peer average 2.42/device2019-02: 0 reports for this device; peer average 3.53/device2019-03: 0 reports for this device; peer average 2.95/device2019-04: 0 reports for this device; peer average 3.13/device2019-05: 0 reports for this device; peer average 2.46/device2019-06: 0 reports for this device; peer average 3.58/device2019-07: 0 reports for this device; peer average 2.42/device2019-08: 0 reports for this device; peer average 2.47/device2019-09: 0 reports for this device; peer average 2.47/device2019-10: 0 reports for this device; peer average 2.71/device2019-11: 0 reports for this device; peer average 2.12/device2019-12: 0 reports for this device; peer average 2.35/device2020-01: 0 reports for this device; peer average 2.55/device2020-02: 0 reports for this device; peer average 2.7/device2020-03: 0 reports for this device; peer average 2.28/device2020-04: 0 reports for this device; peer average 2.54/device2020-05: 0 reports for this device; peer average 1.98/device2020-06: 0 reports for this device; peer average 2.78/device2020-07: 0 reports for this device; peer average 2.77/device2020-08: 0 reports for this device; peer average 4.33/device2020-09: 0 reports for this device; peer average 4.4/device2020-10: 0 reports for this device; peer average 3.99/device2020-11: 0 reports for this device; peer average 4.47/device2020-12: 0 reports for this device; peer average 3.87/device2021-01: 0 reports for this device; peer average 3.99/device2021-02: 0 reports for this device; peer average 3.89/device2021-03: 0 reports for this device; peer average 4.83/device2021-04: 0 reports for this device; peer average 4.7/device2021-05: 0 reports for this device; peer average 4.05/device2021-06: 0 reports for this device; peer average 4.28/device2021-07: 0 reports for this device; peer average 3.88/device2021-08: 1 reports for this device; peer average 3.87/device2021-09: 1 reports for this device; peer average 3.91/device2021-10: 0 reports for this device; peer average 3.99/device2021-11: 0 reports for this device; peer average 3.49/device2021-12: 0 reports for this device; peer average 4.46/device2022-01: 3 reports for this device; peer average 4.57/device2022-02: 0 reports for this device; peer average 5.03/device2022-03: 1 reports for this device; peer average 5.45/device2022-04: 1 reports for this device; peer average 6.48/device2022-05: 0 reports for this device; peer average 5.46/device2022-06: 0 reports for this device; peer average 6.07/device2022-07: 1 reports for this device; peer average 6.34/device2022-08: 2 reports for this device; peer average 6.38/device2022-09: 0 reports for this device; peer average 5.53/device2022-10: 1 reports for this device; peer average 5.35/device2022-11: 0 reports for this device; peer average 5.52/device2022-12: 3 reports for this device; peer average 6/device2023-01: 3 reports for this device; peer average 5.73/device2023-02: 3 reports for this device; peer average 4.87/device2023-03: 3 reports for this device; peer average 5.86/device2023-04: 2 reports for this device; peer average 5.47/device2023-05: 11 reports for this device; peer average 5.86/device2023-06: 3 reports for this device; peer average 7.1/device2023-07: 1 reports for this device; peer average 6.1/device2023-08: 1 reports for this device; peer average 6.28/device2023-09: 1 reports for this device; peer average 5.92/device2023-10: 0 reports for this device; peer average 6.38/device2023-11: 0 reports for this device; peer average 5.76/device2023-12: 1 reports for this device; peer average 6.05/device2024-01: 0 reports for this device; peer average 5.53/device2024-02: 0 reports for this device; peer average 6.18/device2024-03: 1 reports for this device; peer average 5.56/device2024-04: 3 reports for this device; peer average 6.32/device2024-05: 1 reports for this device; peer average 5.3/device2024-06: 0 reports for this device; peer average 7.07/device2024-07: 1 reports for this device; peer average 5.75/device2024-08: 1 reports for this device; peer average 6.5/device2024-09: 1 reports for this device; peer average 6.28/device2024-10: 3 reports for this device; peer average 7.11/device2024-11: 1 reports for this device; peer average 4.55/device2024-12: 1 reports for this device; peer average 4.77/device2025-01: 1 reports for this device; peer average 4.42/device2025-02: 0 reports for this device; peer average 4.03/device2025-03: 2 reports for this device; peer average 5.17/device2025-04: 0 reports for this device; peer average 4.67/device2025-05: 1 reports for this device; peer average 4.69/device2025-06: 0 reports for this device; peer average 4.58/device2025-07: 1 reports for this device; peer average 4.68/device2025-08: 1 reports for this device; peer average 5.45/device2025-09: 1 reports for this device; peer average 3.97/device2025-10: 2 reports for this device; peer average 4.59/device2025-11: 5 reports for this device; peer average 4.86/device2025-12: 1 reports for this device; peer average 6.15/device2026-01: 1 reports for this device; peer average 4.95/device2026-02: 2 reports for this device; peer average 5.05/device2026-03: 3 reports for this device; peer average 5.77/device2026-04: 0 reports for this device; peer average 6.2/device2026-05: 2 reports for this device; peer average 5.86/device2026-06: 3 reports for this device; peer average 5.01/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.42
2019-0203.53
2019-0302.95
2019-0403.13
2019-0502.46
2019-0603.58
2019-0702.42
2019-0802.47
2019-0902.47
2019-1002.71
2019-1102.12
2019-1202.35
2020-0102.55
2020-0202.7
2020-0302.28
2020-0402.54
2020-0501.98
2020-0602.78
2020-0702.77
2020-0804.33
2020-0904.4
2020-1003.99
2020-1104.47
2020-1203.87
2021-0103.99
2021-0203.89
2021-0304.83
2021-0404.7
2021-0504.05
2021-0604.28
2021-0703.88
2021-0813.87
2021-0913.91
2021-1003.99
2021-1103.49
2021-1204.46
2022-0134.57
2022-0205.03
2022-0315.45
2022-0416.48
2022-0505.46
2022-0606.07
2022-0716.34
2022-0826.38
2022-0905.53
2022-1015.35
2022-1105.52
2022-1236
2023-0135.73
2023-0234.87
2023-0335.86
2023-0425.47
2023-05115.86
2023-0637.1
2023-0716.1
2023-0816.28
2023-0915.92
2023-1006.38
2023-1105.76
2023-1216.05
2024-0105.53
2024-0206.18
2024-0315.56
2024-0436.32
2024-0515.3
2024-0607.07
2024-0715.75
2024-0816.5
2024-0916.28
2024-1037.11
2024-1114.55
2024-1214.77
2025-0114.42
2025-0204.03
2025-0325.17
2025-0404.67
2025-0514.69
2025-0604.58
2025-0714.68
2025-0815.45
2025-0913.97
2025-1024.59
2025-1154.86
2025-1216.15
2026-0114.95
2026-0225.05
2026-0335.77
2026-0406.2
2026-0525.86
2026-0635.01
This device (reports/month)Average device in GCJ (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2026-05-14Z-2474-2026Class IIOpen, ClassifiedPotential for overpressure alerts.Distribution: Nationwide distribution. International distribution to Australia, Austria, Belgium, Bosnia and Herzegovina, Canada, CHILE, CHINA, COLOMBIA, Croatia, Denmark, DOMINICAN REPUBLIC, ECUADOR, Egypt, Estonia, Finland, France, Germany, Greece, HONG KONG, India, INDONESIA, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Libya, Luxembourg, MALAYSIA, Malta, Montenegro, Netherlands, NEW ZEALAND, Norway, Oman, Palestine, PANAMA, PHILIPPINES, Poland, Qatar, Romania, Russia, Saudi Arabia, Serbia, SINGAPORE, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, TAIWAN,PROVINCE OF CHINA, THAILAND, Turkey, Ukraine, UNITED ARAB EMIRATES, United Kingdom. .147,013 packs (882,078 eaches)code info di
Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2026-06-293007305485-2026-00142InjuryAvailablecatalog number
2026-06-173007305485-2026-00132InjuryAvailablecatalog number
2026-06-173007305485-2026-00130MalfunctionAvailablecatalog number
2026-05-063007305485-2026-00108MalfunctionAvailablecatalog number
2026-03-163007305485-2026-00040MalfunctionAvailablecatalog number
2026-03-1324589438MalfunctionAvailablecatalog number
2026-02-123007305485-2026-00015InjuryAvailablecatalog number
2026-01-163007305485-2026-00007MalfunctionAvailablecatalog number
2025-12-313007305485-2025-00210MalfunctionAvailablecatalog number
2025-11-133007305485-2025-00182MalfunctionAvailablecatalog number
2025-11-123007305485-2025-00180InjuryAvailablecatalog number
2025-11-103007305485-2025-00177MalfunctionAvailablecatalog number
2025-10-083007305485-2025-00165MalfunctionAvailableexact di
2025-10-073007305485-2025-00164MalfunctionAvailableexact di
2025-09-303007305485-2025-00163InjuryAvailableexact di

Showing the most recent 74 of 82 linked reports.

Showing 1–15 of 74
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
    2026-05-13NAINo action indicatedBiorez, Inc0
    2026-04-06VAIVoluntary action indicatedConMed Corporation6
    2026-04-06VAIVoluntary action indicatedConMed Corporation6
    2023-12-14NAINo action indicatedLinvatec Corp.0
    2023-08-04VAIVoluntary action indicatedBiorez, Inc1
    2022-11-10NAINo action indicatedConMed Corporation0
    2022-11-10NAINo action indicatedConMed Corporation0
    2022-07-13NAINo action indicatedConMed Corporation0
    2022-07-13NAINo action indicatedConMed Corporation0
    2020-09-22VAIVoluntary action indicatedConMed Corporation0
    2020-09-22VAIVoluntary action indicatedConMed Corporation0
    2019-10-17NAINo action indicatedConMed Corporation0
    2019-10-17NAINo action indicatedConMed Corporation0
    2017-02-03VAIVoluntary action indicatedConMed Corporation2
    2017-02-03VAIVoluntary action indicatedConMed Corporation2
    2017-01-23NAINo action indicatedConmed0
    2016-02-03VAIVoluntary action indicatedConMed Corporation5
    2016-02-03VAIVoluntary action indicatedConMed Corporation5
    2014-11-18NAINo action indicatedConMed Corporation0
    2014-11-18NAINo action indicatedConMed Corporation0
    2014-01-29WLWarning LetterConMed Corporation—
    2014-01-29WLWarning LetterConMed Corporation—
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