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Unnamed device

Model 04.500.251 · Synthes GmbH · DI 10887587016894

MQN — External Mandibular Fixator And/Or Distractor · Class II · 21 CFR 872.4760

UDILibrary device dossier · generated 2026-09-15 · 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.

Injury: 1 · Malfunction: 1

368112019-01: 1 reports for this device; peer average 1/device2019-02: 0 reports for this device; peer average 1.18/device2019-03: 0 reports for this device; peer average 1.36/device2019-04: 0 reports for this device; peer average 1/device2019-05: 0 reports for this device; peer average 1/device2019-07: 0 reports for this device; peer average 1/device2019-08: 0 reports for this device; peer average 1/device2019-09: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 1.4/device2019-11: 0 reports for this device; peer average 1/device2019-12: 0 reports for this device; peer average 1.18/device2020-01: 0 reports for this device; peer average 1/device2020-02: 1 reports for this device; peer average 1.11/device2020-03: 0 reports for this device; peer average 1/device2020-04: 0 reports for this device; peer average 1/device2020-05: 0 reports for this device; peer average 4/device2020-06: 0 reports for this device; peer average 1/device2020-07: 0 reports for this device; peer average 1/device2020-08: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 1.13/device2020-10: 0 reports for this device; peer average 1/device2020-11: 0 reports for this device; peer average 1.25/device2020-12: 0 reports for this device; peer average 1/device2021-01: 0 reports for this device; peer average 1/device2021-02: 0 reports for this device; peer average 1/device2021-03: 0 reports for this device; peer average 1/device2021-04: 0 reports for this device; peer average 1/device2021-05: 0 reports for this device; peer average 1.14/device2021-06: 0 reports for this device; peer average 1/device2021-07: 0 reports for this device; peer average 1/device2021-08: 0 reports for this device; peer average 1/device2021-09: 0 reports for this device; peer average 1/device2021-10: 0 reports for this device; peer average 1/device2021-11: 0 reports for this device; peer average 1/device2021-12: 0 reports for this device; peer average 1.2/device2022-01: 0 reports for this device; peer average 1/device2022-03: 0 reports for this device; peer average 1/device2022-04: 0 reports for this device; peer average 1.5/device2022-05: 0 reports for this device; peer average 1/device2022-06: 0 reports for this device; peer average 1/device2022-07: 0 reports for this device; peer average 1/device2022-08: 0 reports for this device; peer average 1/device2022-09: 0 reports for this device; peer average 1.22/device2022-10: 0 reports for this device; peer average 2.33/device2022-11: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 1/device2023-02: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 11.17/device2023-04: 0 reports for this device; peer average 1.2/device2023-06: 0 reports for this device; peer average 1.25/device2023-07: 0 reports for this device; peer average 1.2/device2023-08: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 1.67/device2023-11: 0 reports for this device; peer average 1/device2023-12: 0 reports for this device; peer average 1/device2024-01: 0 reports for this device; peer average 1.5/device2024-02: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 1/device2024-04: 0 reports for this device; peer average 1/device2024-05: 0 reports for this device; peer average 1/device2024-06: 0 reports for this device; peer average 1/device2024-07: 0 reports for this device; peer average 1.33/device2024-08: 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/device2025-01: 0 reports for this device; peer average 1/device2025-02: 0 reports for this device; peer average 1/device2025-04: 0 reports for this device; peer average 1/device2025-05: 0 reports for this device; peer average 1/device2025-06: 0 reports for this device; peer average 1/device2025-07: 0 reports for this device; peer average 2/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 1/device2025-11: 0 reports for this device; peer average 1/device2025-12: 0 reports for this device; peer average 1.5/device2026-01: 0 reports for this device; peer average 1.5/device2026-02: 0 reports for this device; peer average 1.5/device2026-04: 0 reports for this device; peer average 1/device2026-05: 0 reports for this device; peer average 2/device2026-06: 0 reports for this device; peer average 2/device010203040507080910111201020304050607080910111201020304050607080910111201030405060708091011120203040607081011120102030405060708101101020405060708091011120102040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0111
2019-0201.18
2019-0301.36
2019-0401
2019-0501
2019-0701
2019-0801
2019-0901
2019-1001.4
2019-1101
2019-1201.18
2020-0101
2020-0211.11
2020-0301
2020-0401
2020-0504
2020-0601
2020-0701
2020-0801
2020-0901.13
2020-1001
2020-1101.25
2020-1201
2021-0101
2021-0201
2021-0301
2021-0401
2021-0501.14
2021-0601
2021-0701
2021-0801
2021-0901
2021-1001
2021-1101
2021-1201.2
2022-0101
2022-0301
2022-0401.5
2022-0501
2022-0601
2022-0701
2022-0801
2022-0901.22
2022-1002.33
2022-1101
2022-1201
2023-0201
2023-03011.17
2023-0401.2
2023-0601.25
2023-0701.2
2023-0801
2023-1001.67
2023-1101
2023-1201
2024-0101.5
2024-0201
2024-0301
2024-0401
2024-0501
2024-0601
2024-0701.33
2024-0801
2024-1001
2024-1101
2025-0101
2025-0201
2025-0401
2025-0501
2025-0601
2025-0702
2025-0801
2025-0901
2025-1001
2025-1101
2025-1201.5
2026-0101.5
2026-0201.5
2026-0401
2026-0502
2026-0602
This device (reports/month)Average device in MQN (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K121502 — cites (transitively): K013618 (d1), K043434 (d1), K060138 (d1), K080153 (d1) — cited as predicate by K162594, K183113

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Synthes GmbH

  • Warning Letter 2012-02-16 Synthes, Inc.
  • NAI 2017-08-08 Synthes GmbH · 0 citations
  • NAI 2017-01-18 Synthes (USA), LLC · 0 citations
  • VAI 2015-05-08 Synthes (USA), LLC · 2 citations
  • VAI 2013-11-13 Synthes, Inc. · 1 citations
  • NAI 2013-05-16 Synthes, Inc. · 0 citations
  • VAI 2012-10-19 Synthes, Inc. · 1 citations
  • NAI 2012-02-01 Synthes (USA), LLC · 0 citations
  • OAI 2011-09-15 Synthes, Inc. · 10 citations