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AxiEM™

Model 9735017 · MEDTRONIC NAVIGATION, INC. · DI 00763000738372

PGW — Ear, Nose, And Throat Stereotaxic Instrument · Class II · 21 CFR 882.4560

UDILibrary device dossier · generated 2026-09-07 · 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 (11)

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: 11

61117222019-01: 1 reports for this device; peer average 2.75/device2019-02: 0 reports for this device; peer average 3/device2019-03: 0 reports for this device; peer average 4.67/device2019-04: 0 reports for this device; peer average 2.44/device2019-05: 0 reports for this device; peer average 22/device2019-06: 2 reports for this device; peer average 4.25/device2019-07: 0 reports for this device; peer average 6/device2019-08: 0 reports for this device; peer average 7/device2019-09: 2 reports for this device; peer average 2.2/device2019-10: 0 reports for this device; peer average 1.75/device2019-11: 0 reports for this device; peer average 1.25/device2019-12: 0 reports for this device; peer average 5/device2020-01: 0 reports for this device; peer average 1.5/device2020-02: 0 reports for this device; peer average 2.4/device2020-03: 0 reports for this device; peer average 6/device2020-04: 0 reports for this device; peer average 1.5/device2020-05: 0 reports for this device; peer average 2/device2020-06: 0 reports for this device; peer average 2.4/device2020-07: 0 reports for this device; peer average 3/device2020-08: 0 reports for this device; peer average 5/device2020-09: 0 reports for this device; peer average 1.33/device2020-10: 0 reports for this device; peer average 6/device2020-11: 0 reports for this device; peer average 1.5/device2020-12: 0 reports for this device; peer average 5/device2021-01: 0 reports for this device; peer average 3/device2021-02: 0 reports for this device; peer average 4.5/device2021-03: 0 reports for this device; peer average 8/device2021-04: 0 reports for this device; peer average 5.33/device2021-05: 0 reports for this device; peer average 10.5/device2021-06: 0 reports for this device; peer average 5/device2021-07: 0 reports for this device; peer average 6.67/device2021-08: 0 reports for this device; peer average 5.6/device2021-09: 0 reports for this device; peer average 3.2/device2021-10: 0 reports for this device; peer average 3/device2021-11: 0 reports for this device; peer average 3/device2021-12: 0 reports for this device; peer average 3.67/device2022-01: 2 reports for this device; peer average 2.5/device2022-02: 0 reports for this device; peer average 3.75/device2022-03: 0 reports for this device; peer average 4.5/device2022-04: 0 reports for this device; peer average 3/device2022-05: 0 reports for this device; peer average 4.5/device2022-06: 0 reports for this device; peer average 2.89/device2022-07: 0 reports for this device; peer average 3.75/device2022-08: 0 reports for this device; peer average 3/device2022-09: 0 reports for this device; peer average 2.33/device2022-10: 0 reports for this device; peer average 5.5/device2022-11: 0 reports for this device; peer average 5.2/device2022-12: 0 reports for this device; peer average 2.25/device2023-01: 0 reports for this device; peer average 4.83/device2023-02: 0 reports for this device; peer average 2.67/device2023-03: 0 reports for this device; peer average 3.11/device2023-04: 0 reports for this device; peer average 3.5/device2023-05: 0 reports for this device; peer average 5.17/device2023-06: 0 reports for this device; peer average 3/device2023-07: 0 reports for this device; peer average 3.5/device2023-08: 0 reports for this device; peer average 3.8/device2023-09: 0 reports for this device; peer average 2.89/device2023-10: 0 reports for this device; peer average 2.5/device2023-11: 0 reports for this device; peer average 2.89/device2023-12: 0 reports for this device; peer average 4.11/device2024-01: 0 reports for this device; peer average 2/device2024-02: 0 reports for this device; peer average 3.25/device2024-03: 0 reports for this device; peer average 2.7/device2024-04: 0 reports for this device; peer average 4.09/device2024-05: 0 reports for this device; peer average 2.73/device2024-06: 1 reports for this device; peer average 2.33/device2024-07: 0 reports for this device; peer average 3/device2024-08: 0 reports for this device; peer average 6.67/device2024-09: 1 reports for this device; peer average 2/device2024-10: 0 reports for this device; peer average 4.6/device2024-11: 0 reports for this device; peer average 4.83/device2024-12: 0 reports for this device; peer average 3.8/device2025-01: 1 reports for this device; peer average 1.92/device2025-02: 0 reports for this device; peer average 4.65/device2025-03: 0 reports for this device; peer average 3.43/device2025-04: 0 reports for this device; peer average 1.93/device2025-05: 0 reports for this device; peer average 5.67/device2025-06: 0 reports for this device; peer average 8.5/device2025-07: 0 reports for this device; peer average 1.75/device2025-08: 0 reports for this device; peer average 4/device2025-09: 0 reports for this device; peer average 3/device2025-10: 0 reports for this device; peer average 2.4/device2025-11: 0 reports for this device; peer average 4.5/device2025-12: 1 reports for this device; peer average 2/device2026-01: 0 reports for this device; peer average 2.1/device2026-02: 0 reports for this device; peer average 2.33/device2026-03: 0 reports for this device; peer average 6.5/device2026-04: 0 reports for this device; peer average 1.38/device2026-05: 0 reports for this device; peer average 3/device2026-06: 0 reports for this device; peer average 2/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0112.75
2019-0203
2019-0304.67
2019-0402.44
2019-05022
2019-0624.25
2019-0706
2019-0807
2019-0922.2
2019-1001.75
2019-1101.25
2019-1205
2020-0101.5
2020-0202.4
2020-0306
2020-0401.5
2020-0502
2020-0602.4
2020-0703
2020-0805
2020-0901.33
2020-1006
2020-1101.5
2020-1205
2021-0103
2021-0204.5
2021-0308
2021-0405.33
2021-05010.5
2021-0605
2021-0706.67
2021-0805.6
2021-0903.2
2021-1003
2021-1103
2021-1203.67
2022-0122.5
2022-0203.75
2022-0304.5
2022-0403
2022-0504.5
2022-0602.89
2022-0703.75
2022-0803
2022-0902.33
2022-1005.5
2022-1105.2
2022-1202.25
2023-0104.83
2023-0202.67
2023-0303.11
2023-0403.5
2023-0505.17
2023-0603
2023-0703.5
2023-0803.8
2023-0902.89
2023-1002.5
2023-1102.89
2023-1204.11
2024-0102
2024-0203.25
2024-0302.7
2024-0404.09
2024-0502.73
2024-0612.33
2024-0703
2024-0806.67
2024-0912
2024-1004.6
2024-1104.83
2024-1203.8
2025-0111.92
2025-0204.65
2025-0303.43
2025-0401.93
2025-0505.67
2025-0608.5
2025-0701.75
2025-0804
2025-0903
2025-1002.4
2025-1104.5
2025-1212
2026-0102.1
2026-0202.33
2026-0306.5
2026-0401.38
2026-0503
2026-0602
This device (reports/month)Average device in PGW (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — MEDTRONIC NAVIGATION, INC.

  • Warning Letter 2010-05-07 Medtronic Navigation, Inc.
  • VAI 2024-02-09 Medtronic Navigation, Inc. · 3 citations
  • VAI 2021-06-29 Medtronic Navigation, Inc. · 3 citations
  • VAI 2019-09-30 Medtronic Navigation, Inc. · 1 citations
  • VAI 2016-08-18 Medtronic Navigation, Inc. · 0 citations
  • NAI 2014-12-15 Medtronic Navigation, Inc. · 0 citations
  • VAI 2014-02-19 Medtronic Navigation, Inc. · 5 citations
  • NAI 2012-09-06 Medtronic Navigation, Inc. · 0 citations
  • NAI 2012-05-01 Medtronic Navigation, Inc. · 0 citations
  • VAI 2011-03-24 Medtronic Navigation, Inc. · 1 citations
  • OAI 2010-02-04 Medtronic Navigation, Inc. · 9 citations