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Unnamed device

Model 5407FA2023 · STRYKER CORPORATION · DI 07613327096729

HBE — Drills, Burrs, Trephines & Accessories (Simple, Powered) · Class II · 21 CFR 882.4310

UDILibrary device dossier · generated 2026-09-06 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (144)

Caveat (required reading): 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 is a reporting baseline (average device in the same product code), not a risk measure.

Malfunction: 135 · Injury: 9

4811152019-01: 1 reports for this device; peer average 2.29/device2019-02: 0 reports for this device; peer average 3.68/device2019-03: 0 reports for this device; peer average 4.9/device2019-04: 1 reports for this device; peer average 3.39/device2019-05: 0 reports for this device; peer average 4/device2019-06: 1 reports for this device; peer average 3.65/device2019-07: 3 reports for this device; peer average 3.23/device2019-08: 2 reports for this device; peer average 3.89/device2019-09: 0 reports for this device; peer average 2.94/device2019-10: 5 reports for this device; peer average 3/device2019-11: 3 reports for this device; peer average 3.32/device2019-12: 1 reports for this device; peer average 3.76/device2020-01: 0 reports for this device; peer average 3.19/device2020-02: 1 reports for this device; peer average 6.36/device2020-03: 1 reports for this device; peer average 5.11/device2020-04: 2 reports for this device; peer average 3.12/device2020-05: 1 reports for this device; peer average 2.9/device2020-06: 1 reports for this device; peer average 4.24/device2020-07: 0 reports for this device; peer average 3.8/device2020-08: 3 reports for this device; peer average 3.06/device2020-09: 5 reports for this device; peer average 4.6/device2020-10: 4 reports for this device; peer average 3.78/device2020-11: 7 reports for this device; peer average 4.29/device2020-12: 3 reports for this device; peer average 4.34/device2021-01: 3 reports for this device; peer average 3.3/device2021-02: 0 reports for this device; peer average 3.03/device2021-03: 3 reports for this device; peer average 3.51/device2021-04: 0 reports for this device; peer average 2.92/device2021-05: 1 reports for this device; peer average 2.73/device2021-06: 3 reports for this device; peer average 3.62/device2021-07: 10 reports for this device; peer average 3.29/device2021-08: 2 reports for this device; peer average 4.9/device2021-09: 4 reports for this device; peer average 3.59/device2021-10: 0 reports for this device; peer average 2.88/device2021-11: 1 reports for this device; peer average 3.54/device2021-12: 0 reports for this device; peer average 4.3/device2022-01: 1 reports for this device; peer average 2.93/device2022-02: 1 reports for this device; peer average 3.79/device2022-03: 3 reports for this device; peer average 3.94/device2022-04: 0 reports for this device; peer average 2.55/device2022-05: 3 reports for this device; peer average 3.36/device2022-06: 3 reports for this device; peer average 3.9/device2022-07: 1 reports for this device; peer average 3.02/device2022-08: 2 reports for this device; peer average 3.9/device2022-09: 4 reports for this device; peer average 4.04/device2022-10: 2 reports for this device; peer average 3.41/device2022-11: 7 reports for this device; peer average 3.62/device2022-12: 9 reports for this device; peer average 4.61/device2023-01: 0 reports for this device; peer average 3.21/device2023-02: 3 reports for this device; peer average 3.83/device2023-03: 7 reports for this device; peer average 3.93/device2023-04: 0 reports for this device; peer average 3.25/device2023-05: 2 reports for this device; peer average 4.68/device2023-06: 0 reports for this device; peer average 4.04/device2023-07: 2 reports for this device; peer average 2.9/device2023-08: 0 reports for this device; peer average 3.5/device2023-09: 0 reports for this device; peer average 3.58/device2023-10: 1 reports for this device; peer average 2.62/device2023-11: 0 reports for this device; peer average 4.11/device2023-12: 1 reports for this device; peer average 2.85/device2024-01: 1 reports for this device; peer average 3.18/device2024-02: 0 reports for this device; peer average 3.13/device2024-03: 1 reports for this device; peer average 3.59/device2024-04: 1 reports for this device; peer average 2.68/device2024-05: 0 reports for this device; peer average 2.7/device2024-06: 0 reports for this device; peer average 3.29/device2024-07: 1 reports for this device; peer average 2.6/device2024-08: 0 reports for this device; peer average 2.75/device2024-09: 1 reports for this device; peer average 3.49/device2024-10: 2 reports for this device; peer average 2.67/device2024-11: 0 reports for this device; peer average 2.16/device2024-12: 0 reports for this device; peer average 3.35/device2025-01: 2 reports for this device; peer average 2.56/device2025-02: 0 reports for this device; peer average 3.52/device2025-03: 1 reports for this device; peer average 2.34/device2025-04: 1 reports for this device; peer average 1.85/device2025-05: 0 reports for this device; peer average 2.19/device2025-06: 0 reports for this device; peer average 2.48/device2025-07: 1 reports for this device; peer average 2.47/device2025-08: 0 reports for this device; peer average 1.85/device2025-09: 1 reports for this device; peer average 2/device2025-10: 3 reports for this device; peer average 2.75/device2025-11: 0 reports for this device; peer average 3.08/device2025-12: 0 reports for this device; peer average 2.91/device2026-01: 1 reports for this device; peer average 2.01/device2026-02: 0 reports for this device; peer average 2.5/device2026-03: 0 reports for this device; peer average 4.3/device2026-04: 1 reports for this device; peer average 4.4/device2026-05: 1 reports for this device; peer average 4.84/device2026-06: 1 reports for this device; peer average 15.24/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0112.29
2019-0203.68
2019-0304.9
2019-0413.39
2019-0504
2019-0613.65
2019-0733.23
2019-0823.89
2019-0902.94
2019-1053
2019-1133.32
2019-1213.76
2020-0103.19
2020-0216.36
2020-0315.11
2020-0423.12
2020-0512.9
2020-0614.24
2020-0703.8
2020-0833.06
2020-0954.6
2020-1043.78
2020-1174.29
2020-1234.34
2021-0133.3
2021-0203.03
2021-0333.51
2021-0402.92
2021-0512.73
2021-0633.62
2021-07103.29
2021-0824.9
2021-0943.59
2021-1002.88
2021-1113.54
2021-1204.3
2022-0112.93
2022-0213.79
2022-0333.94
2022-0402.55
2022-0533.36
2022-0633.9
2022-0713.02
2022-0823.9
2022-0944.04
2022-1023.41
2022-1173.62
2022-1294.61
2023-0103.21
2023-0233.83
2023-0373.93
2023-0403.25
2023-0524.68
2023-0604.04
2023-0722.9
2023-0803.5
2023-0903.58
2023-1012.62
2023-1104.11
2023-1212.85
2024-0113.18
2024-0203.13
2024-0313.59
2024-0412.68
2024-0502.7
2024-0603.29
2024-0712.6
2024-0802.75
2024-0913.49
2024-1022.67
2024-1102.16
2024-1203.35
2025-0122.56
2025-0203.52
2025-0312.34
2025-0411.85
2025-0502.19
2025-0602.48
2025-0712.47
2025-0801.85
2025-0912
2025-1032.75
2025-1103.08
2025-1202.91
2026-0112.01
2026-0202.5
2026-0304.3
2026-0414.4
2026-0514.84
2026-06115.24
This device (reports/month)Average device in HBE (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — STRYKER CORPORATION

  • Warning Letter 2017-04-06 Entellus Medical Inc.
  • Warning Letter 2015-04-08 Thermedx LLC
  • Injunction 2013-11-26 Physio-Control, Inc.
  • Warning Letter 2013-03-06 Stryker Corporation
  • Warning Letter 2013-03-06 Stryker Corporation
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  • VAI 2026-02-20 Stryker Puerto Rico, LLC · 2 citations
  • NAI 2025-12-11 Stryker Manufacturing Kalamazoo · 0 citations
  • NAI 2025-05-22 Stryker Macroom · 0 citations
  • VAI 2025-03-27 Stryker GmbH · 1 citations
  • VAI 2025-03-27 Stryker GmbH · 1 citations
  • NAI 2025-02-27 Stryker Leibinger GmbH & Co. KG · 0 citations
  • NAI 2025-01-30 Serf · 0 citations
  • VAI 2024-12-18 Stryker Neurovascular · 1 citations
  • VAI 2024-11-15 Stryker Medical Division of Stryker Corporation · 2 citations
  • NAI 2024-11-13 POM Medical LLC · 0 citations
  • VAI 2024-07-25 Stryker Ireland, Ltd., Instruments Division · 1 citations
  • NAI 2024-05-03 Stryker Neurovascular, Inc. · 0 citations
  • NAI 2024-04-18 Physio-Control, Inc. · 0 citations
  • VAI 2023-12-01 Howmedica Osteonics Corp. · 1 citations
  • VAI 2023-05-15 LimFlow, Inc. · 2 citations
  • NAI 2023-04-25 Stryker Puerto Rico, LLC · 0 citations
  • VAI 2023-01-24 Stryker Corporation · 2 citations
  • VAI 2023-01-24 Stryker Corporation · 2 citations
  • VAI 2022-03-08 POM Medical LLC · 0 citations