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Millennium

Model Z16113001 · Avalign Technologies, Inc. · DI 00190776135072

JDW — Pin, Fixation, Threaded · Class II · 21 CFR 888.3040

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 (2)

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: 2

4913172019-01: 0 reports for this device; peer average 1.83/device2019-02: 0 reports for this device; peer average 2/device2019-03: 0 reports for this device; peer average 1/device2019-04: 0 reports for this device; peer average 2/device2019-05: 0 reports for this device; peer average 2/device2019-06: 0 reports for this device; peer average 1.33/device2019-07: 0 reports for this device; peer average 1.25/device2019-08: 0 reports for this device; peer average 17/device2019-09: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 1/device2019-11: 0 reports for this device; peer average 2.67/device2019-12: 0 reports for this device; peer average 3/device2020-01: 2 reports for this device; peer average 5/device2020-02: 0 reports for this device; peer average 2/device2020-03: 0 reports for this device; peer average 1.8/device2020-05: 0 reports for this device; peer average 2.5/device2020-06: 0 reports for this device; peer average 2.33/device2020-07: 0 reports for this device; peer average 1.33/device2020-08: 0 reports for this device; peer average 1.5/device2020-10: 0 reports for this device; peer average 1.33/device2020-11: 0 reports for this device; peer average 2.83/device2020-12: 0 reports for this device; peer average 2.5/device2021-01: 0 reports for this device; peer average 1.5/device2021-02: 0 reports for this device; peer average 3.33/device2021-03: 0 reports for this device; peer average 6/device2021-04: 0 reports for this device; peer average 2.11/device2021-05: 0 reports for this device; peer average 12.29/device2021-06: 0 reports for this device; peer average 2.83/device2021-07: 0 reports for this device; peer average 2/device2021-08: 0 reports for this device; peer average 2/device2021-09: 0 reports for this device; peer average 1.25/device2021-10: 0 reports for this device; peer average 2/device2021-11: 0 reports for this device; peer average 3/device2021-12: 0 reports for this device; peer average 1.5/device2022-01: 0 reports for this device; peer average 2/device2022-02: 0 reports for this device; peer average 2.67/device2022-03: 0 reports for this device; peer average 1.75/device2022-04: 0 reports for this device; peer average 3/device2022-05: 0 reports for this device; peer average 1.33/device2022-06: 0 reports for this device; peer average 3/device2022-07: 0 reports for this device; peer average 2.5/device2022-08: 0 reports for this device; peer average 1.5/device2022-09: 0 reports for this device; peer average 1.67/device2022-10: 0 reports for this device; peer average 1.75/device2022-11: 0 reports for this device; peer average 3/device2022-12: 0 reports for this device; peer average 2/device2023-01: 0 reports for this device; peer average 1.33/device2023-02: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 1.2/device2023-04: 0 reports for this device; peer average 1.33/device2023-05: 0 reports for this device; peer average 1.5/device2023-06: 0 reports for this device; peer average 1/device2023-07: 0 reports for this device; peer average 1.2/device2023-09: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 1/device2023-11: 0 reports for this device; peer average 3/device2024-01: 0 reports for this device; peer average 1/device2024-02: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 1.33/device2024-04: 0 reports for this device; peer average 2/device2024-05: 0 reports for this device; peer average 1.4/device2024-06: 0 reports for this device; peer average 1.5/device2024-07: 0 reports for this device; peer average 1/device2024-08: 0 reports for this device; peer average 1.6/device2024-09: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 1/device2024-11: 0 reports for this device; peer average 1.5/device2024-12: 0 reports for this device; peer average 2/device2025-01: 0 reports for this device; peer average 2/device2025-02: 0 reports for this device; peer average 2.83/device2025-06: 0 reports for this device; peer average 1.33/device2025-08: 0 reports for this device; peer average 1/device2025-09: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 2/device2025-11: 0 reports for this device; peer average 1.5/device2025-12: 0 reports for this device; peer average 1.25/device2026-01: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 2/device2026-03: 0 reports for this device; peer average 1.4/device2026-04: 0 reports for this device; peer average 1/device2026-05: 0 reports for this device; peer average 1.5/device2026-06: 0 reports for this device; peer average 1/device01020304050607080910111201020305060708101112010203040506070809101112010203040506070809101112010203040506070910110102030405060708091011120102060809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.83
2019-0202
2019-0301
2019-0402
2019-0502
2019-0601.33
2019-0701.25
2019-08017
2019-0901
2019-1001
2019-1102.67
2019-1203
2020-0125
2020-0202
2020-0301.8
2020-0502.5
2020-0602.33
2020-0701.33
2020-0801.5
2020-1001.33
2020-1102.83
2020-1202.5
2021-0101.5
2021-0203.33
2021-0306
2021-0402.11
2021-05012.29
2021-0602.83
2021-0702
2021-0802
2021-0901.25
2021-1002
2021-1103
2021-1201.5
2022-0102
2022-0202.67
2022-0301.75
2022-0403
2022-0501.33
2022-0603
2022-0702.5
2022-0801.5
2022-0901.67
2022-1001.75
2022-1103
2022-1202
2023-0101.33
2023-0201
2023-0301.2
2023-0401.33
2023-0501.5
2023-0601
2023-0701.2
2023-0901
2023-1001
2023-1103
2024-0101
2024-0201
2024-0301.33
2024-0402
2024-0501.4
2024-0601.5
2024-0701
2024-0801.6
2024-0901
2024-1001
2024-1101.5
2024-1202
2025-0102
2025-0202.83
2025-0601.33
2025-0801
2025-0901
2025-1002
2025-1101.5
2025-1201.25
2026-0101
2026-0202
2026-0301.4
2026-0401
2026-0501.5
2026-0601
This device (reports/month)Average device in JDW (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