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Millennium

Model 85-1511023 · Avalign Technologies, Inc. · DI 00190776118211

HTW — Bit, Drill · Class I · 21 CFR 888.4540

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 (3)

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: 3

23572019-01: 0 reports for this device; peer average 3.47/device2019-02: 0 reports for this device; peer average 3.86/device2019-03: 0 reports for this device; peer average 2.58/device2019-04: 0 reports for this device; peer average 2.41/device2019-05: 0 reports for this device; peer average 2.64/device2019-06: 0 reports for this device; peer average 2.8/device2019-07: 0 reports for this device; peer average 2.3/device2019-08: 0 reports for this device; peer average 2.82/device2019-09: 0 reports for this device; peer average 3.22/device2019-10: 0 reports for this device; peer average 3.71/device2019-11: 0 reports for this device; peer average 4.55/device2019-12: 0 reports for this device; peer average 4.16/device2020-01: 0 reports for this device; peer average 4.68/device2020-02: 0 reports for this device; peer average 4.03/device2020-03: 0 reports for this device; peer average 4.19/device2020-04: 0 reports for this device; peer average 3.19/device2020-05: 0 reports for this device; peer average 3/device2020-06: 0 reports for this device; peer average 4.08/device2020-07: 0 reports for this device; peer average 5.14/device2020-08: 0 reports for this device; peer average 5.73/device2020-09: 0 reports for this device; peer average 4.59/device2020-10: 0 reports for this device; peer average 4.66/device2020-11: 0 reports for this device; peer average 4.89/device2020-12: 0 reports for this device; peer average 5.09/device2021-01: 0 reports for this device; peer average 5.21/device2021-02: 0 reports for this device; peer average 3.53/device2021-03: 0 reports for this device; peer average 4.11/device2021-04: 0 reports for this device; peer average 3.96/device2021-05: 0 reports for this device; peer average 5/device2021-06: 0 reports for this device; peer average 5/device2021-07: 0 reports for this device; peer average 3.89/device2021-08: 0 reports for this device; peer average 4.29/device2021-09: 0 reports for this device; peer average 5.44/device2021-10: 0 reports for this device; peer average 4/device2021-11: 0 reports for this device; peer average 4.57/device2021-12: 0 reports for this device; peer average 4.27/device2022-01: 0 reports for this device; peer average 4.78/device2022-02: 0 reports for this device; peer average 5.09/device2022-03: 0 reports for this device; peer average 4.49/device2022-04: 0 reports for this device; peer average 4.85/device2022-05: 0 reports for this device; peer average 3.57/device2022-06: 0 reports for this device; peer average 4.53/device2022-07: 0 reports for this device; peer average 2.83/device2022-08: 0 reports for this device; peer average 4.69/device2022-09: 0 reports for this device; peer average 3.98/device2022-10: 0 reports for this device; peer average 4.17/device2022-11: 0 reports for this device; peer average 4.34/device2022-12: 0 reports for this device; peer average 5.85/device2023-01: 0 reports for this device; peer average 4.46/device2023-02: 0 reports for this device; peer average 4.28/device2023-03: 0 reports for this device; peer average 6.93/device2023-04: 0 reports for this device; peer average 5.88/device2023-05: 0 reports for this device; peer average 5.33/device2023-06: 0 reports for this device; peer average 5.07/device2023-07: 0 reports for this device; peer average 4.25/device2023-08: 0 reports for this device; peer average 3.35/device2023-09: 0 reports for this device; peer average 2.79/device2023-10: 1 reports for this device; peer average 3.59/device2023-11: 2 reports for this device; peer average 3.05/device2023-12: 0 reports for this device; peer average 2.69/device2024-01: 0 reports for this device; peer average 2.35/device2024-02: 0 reports for this device; peer average 3.27/device2024-03: 0 reports for this device; peer average 2.5/device2024-04: 0 reports for this device; peer average 4.28/device2024-05: 0 reports for this device; peer average 3.05/device2024-06: 0 reports for this device; peer average 2.75/device2024-07: 0 reports for this device; peer average 2.56/device2024-08: 0 reports for this device; peer average 3.13/device2024-09: 0 reports for this device; peer average 2.57/device2024-10: 0 reports for this device; peer average 3.41/device2024-11: 0 reports for this device; peer average 3.69/device2024-12: 0 reports for this device; peer average 2.59/device2025-01: 0 reports for this device; peer average 4.12/device2025-02: 0 reports for this device; peer average 2.43/device2025-03: 0 reports for this device; peer average 3.12/device2025-04: 0 reports for this device; peer average 3.12/device2025-05: 0 reports for this device; peer average 4.59/device2025-06: 0 reports for this device; peer average 3.47/device2025-07: 0 reports for this device; peer average 3.32/device2025-08: 0 reports for this device; peer average 3.84/device2025-09: 0 reports for this device; peer average 2.91/device2025-10: 0 reports for this device; peer average 3.13/device2025-11: 0 reports for this device; peer average 4/device2025-12: 0 reports for this device; peer average 3.79/device2026-01: 0 reports for this device; peer average 3.38/device2026-02: 0 reports for this device; peer average 2.4/device2026-03: 0 reports for this device; peer average 3.9/device2026-04: 0 reports for this device; peer average 4.21/device2026-05: 0 reports for this device; peer average 3.76/device2026-06: 0 reports for this device; peer average 3.77/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0103.47
2019-0203.86
2019-0302.58
2019-0402.41
2019-0502.64
2019-0602.8
2019-0702.3
2019-0802.82
2019-0903.22
2019-1003.71
2019-1104.55
2019-1204.16
2020-0104.68
2020-0204.03
2020-0304.19
2020-0403.19
2020-0503
2020-0604.08
2020-0705.14
2020-0805.73
2020-0904.59
2020-1004.66
2020-1104.89
2020-1205.09
2021-0105.21
2021-0203.53
2021-0304.11
2021-0403.96
2021-0505
2021-0605
2021-0703.89
2021-0804.29
2021-0905.44
2021-1004
2021-1104.57
2021-1204.27
2022-0104.78
2022-0205.09
2022-0304.49
2022-0404.85
2022-0503.57
2022-0604.53
2022-0702.83
2022-0804.69
2022-0903.98
2022-1004.17
2022-1104.34
2022-1205.85
2023-0104.46
2023-0204.28
2023-0306.93
2023-0405.88
2023-0505.33
2023-0605.07
2023-0704.25
2023-0803.35
2023-0902.79
2023-1013.59
2023-1123.05
2023-1202.69
2024-0102.35
2024-0203.27
2024-0302.5
2024-0404.28
2024-0503.05
2024-0602.75
2024-0702.56
2024-0803.13
2024-0902.57
2024-1003.41
2024-1103.69
2024-1202.59
2025-0104.12
2025-0202.43
2025-0303.12
2025-0403.12
2025-0504.59
2025-0603.47
2025-0703.32
2025-0803.84
2025-0902.91
2025-1003.13
2025-1104
2025-1203.79
2026-0103.38
2026-0202.4
2026-0303.9
2026-0404.21
2026-0503.76
2026-0603.77
This device (reports/month)Average device in HTW (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Avalign Technologies, Inc.

  • Warning Letter 2014-03-28 Instrumed GmbH
  • VAI 2023-12-05 Instrumed International Inc · 5 citations
  • VAI 2022-06-28 Avalign Integrated Medical Solutions, Inc. · 3 citations
  • VAI 2019-11-20 Instrumed International Inc · 2 citations
  • NAI 2018-10-25 Instrumed GmbH · 0 citations
  • NAI 2016-11-30 Instrumed International Inc · 0 citations
  • NAI 2015-09-22 Millennium Surgical Corp · 0 citations
  • NAI 2015-01-29 Instrumed GmbH · 0 citations
  • VAI 2013-08-20 Instrumed International Inc · 17 citations
  • OAI 2013-08-01 Instrumed GmbH · 0 citations
  • VAI 2013-04-24 Avalign Integrated Medical Solutions, Inc. · 4 citations
  • NAI 2011-02-28 Instrumed International Inc · 0 citations